Voices In Validation: Recent Episodes
IVT Network
Our host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.
The pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. Poor laboratory practice may yield compliance issues, higher costs, increased cycle time, and delayed product introductions. Avoiding all that means consistent lab review processes and good document controls. Here to review effective laboratory review processes, and their importance to regulatory compliance is David Strauss of SciCord.
About Our Guest:
David Strauss, CEO and Founder, SciCord
David co-founded SciCord LLC in 2014. SciCord implemented the first production ELN solution in 2015 and has continued to grow both in functionality and customer base. SciCord’s solution has evolved to encompass integrated ELN & LIMS functionality with plug-and-play modules preconfigured to automate many laboratory functions.
Prior to 2014, David created an ELN application for GSK which virtually eliminated paper from the worldwide pre-clinical organization and was credited with a 30% productivity increase. David grew the application over 15 years to service more than 6000 scientists who in turn created over 800,000 experiments. As ELN champion, David was involved and often led the design, development, testing, validation, implementation, and regulatory compliance defense.
David started his career with Merck, working in the lab and then specializing in information and laboratory automation.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
The much-discussed revision to the EU GMP Annex 1 is expected to be published early this year, bringing some major changes to drug developers’ current process and manufacturing methods for sterile products. Although the draft revision has been widely shared and commented on, it is still unclear the total impact this document may have across regulated industries. Here to share their perspective on the Annex 1 Revision document is Patrick Nieuwenhuizen from PharmaLex.
About Our Guest:
Patrick Nieuwenhuizen, Director, Senior Consultant with PharmaLex Ireland
Patrick is an experienced Quality professional with a Microbiology & Sterile Manufacturing background amassing expertise over the past 25 years in the Pharmaceutical Industry. Patrick has worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines, and Solid Oral Dose. He is also a qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design/Upgrade, and risk facilitator for Quality Risk Management.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
We have entered an era of accelerated digitalization in Life Sciences. Innovation has been thrust upon many across industries as a need to work remotely, automating tasks and virtual collaborations were necessary during the pandemic. Maintaining this accelerated pace, fully embracing the adoption of technology and automation, is the next hurdle we face. Will CSA get us there? Here to demystify the CSA shift is Ron Schardong, Sr. Director of Quality at J&J.
About Our Guest:
Ron Schardong is privileged to lead Johnson & Johnson’s Technology Quality group responsible for Quality Management System for IT, Software as Medical Device, Externally Facing Digital Assets, external advocacy, quality strategies for emerging technologies, and digital surgery platforms across Medical Devices, Consumer and Pharmaceutical segments worldwide. He has over 25 years of experience in quality engineering, computer software validation, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of the FICSA Group (FDA + Industry Computer Assurance Group).
Disclaimer: This presentation is intended for educational purposes only and does not replace independent professional judgment. Statements of fact and opinions expressed are those of the participant individually and, unless expressly stated to the contrary, are not the opinion or position of Johnson & Johnson or its affiliates.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Welcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
This week, series coordinator Nuala is joined once again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another old friend of the IVT network, Dr. James Vesper. Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk Tolerance.
About Our Guest:
Dr. Jim Vesper
James Vesper, MPH, Ph.D. established and is president LearningPlus, Inc., and has had more than 30 years experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. Since 1991, he and his firm, LearningPlus, have worked with pharma/biopharma, device, and blood products organizations around the world consulting on risk management, performance solutions, and custom GMP learning events. He has been a special advisor/consultant to the World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities working as a mentor and instructor for a number of different learning courses. Dr. Vesper has written five books, including Risk Assessment and Risk Management: Clear and Simple, and multiple technical articles. He has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia. Dr. Vesper may be contacted at jvesper@learningplus.com.
Resources From This Episode:
What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?
Risk Revolution: The Best of Year One - an Anniversary Episode
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
As we begin to harness the data delivered through AI, and further refine the processes around automation, supply chain, new norms around surface contamination and sanitization, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry.
In drug and device production we are accustomed to concerns about contaminants, and mitigation of impurities, pollutants, and toxins. Heightened awareness around this topic is a direct result of the coronavirus pandemic, which has impacted the way we think and act on cleaning processes and will continue to do so for the long term.
Here today to talk about clean surface technologies and his invention BIOFoam is Scott Smith, CEO of AquaFlex.
About Our Guest:
Scott Smith, CEO and Founder, AquaFlex
Scott is an inventor named on 11 issued patents and 14 patent-pending applications relating to Open-Cell foam technology (AquaFlex® and bioFOAM™) for testing/remediation of water, surfaces, and air contaminated with dangerous pathogens (e.g., MRSA, COVID-19, Legionella, C. diff), harmful algal blooms and related toxins, oil, and chemicals. Smith holds degrees from Baylor University (1987) and Harvard Business School (1991). For more information go to the following websites: Truth About Germs, Go bioFOAM, and Go AquaFlex
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Trending Technologies in Life Sciences - A Special episode series of Voices in Validation
This week, Stacey is joined by Dr. Peter Small, from Hyfe about an AI cough monitor that detects and records every cough and turns that into reliable clinical data.
We are working at accelerated speeds to digitalize and automate across pharmaceutical and medical devices. There are unique challenges inherent to emerging technologies in clinical trials development, scale-up, and manufacture. As we begin to harness the data delivered through AI, and further refine the processes around automation, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry.
About Our Guest:
Dr. Peter Small has had an eclectic career, with the common theme being the use of innovation to improve health care. He was chief medical resident at UCSF during the dawn of the HIV epidemic, did pioneering molecular epidemiologic research at Stanford University, and built and ran the TB program for the Bill and Melinda Gates Foundation.
In 2015, he founded the Global Health Institute at Stony Brook University focused on the use of technology to deliver health care in remote Madagascar and Nepal. In 2019, he stepped in as the technical lead of a Gates-funded design-build firm which he recently left to focus on making cough count.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Justin Bechtel, of Bechtel Recruiting Group. This seems to be the era of the great resignation. Now more than ever in recent history employees have the advantage, and this is true across regulated industries as well. Unfortunately, the amount of training and experience necessary in maintaining GMP standards, delivering quality products, and patient-first service, means this can be an especially challenging environment to recruit, hire and retain. Justin is here to provide some guidance, both for hiring managers and employees, in navigating this volatile job environment.
About Our Guest:
Justin Bechtel, Founder, and Lead Recruiter, Bechtel Recruiting Group
Justin began his career in the medical field where he specialized in pediatric and orthopedic physical therapy. Following the completion of clinical placements and doctoral degree, he moved into business development and recruiting, a career that allowed him to recognize his love of personal interaction and helping others more fully. Justin now works with hiring partners and job seekers, to provide an experience second to none, providing an individualized approach to hiring pain points for employers and hiring managers. He also assists job seekers, by simplifying the hiring job search process, coaching job seekers through the stressful process of job hunting. Justin attributes his success to a work ethic centered around quality, accountability, and honesty for both hiring partners and job seekers.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further.
Resources from this episode:
ICH Q9 Quality Risk Management Revision
Link to the new guidance
Understanding the Concept of Formality In Quality Risk ...
Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution
Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?
Q9R1 presentation
About Our Guest:
Kate Coleman
Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Brian Nunnally, Global Head of Quality Control, Seqirus. Stacey and Brian discuss updates and insights on laboratory operations since the pandemic began.
COVID has changed nearly every facet of society, and many of the changes will be permanent, not returning to the “old ways.” While we often take comfort in the status quo, this pandemic has allowed us many positives too, including better digital capabilities, and a better understanding of technological implications on drug development. New knowledge, new ways of working and collaborating, and improved methods of adaptability make this a perfect time to consider evolving our laboratories to meet new demands and maximize patient safety.
About Our Guest:
Brian K Nunnally, Ph.D., Global Head of Quality Control, Seqirus – A CSL Company
Brian is the Head of Quality Control for Seqirus. Being the best quality control unit drives his passion. Prior to this role, he served as the Site Head of Quality for the Holly Springs Seqirus plant. Before joining Seqirus, he worked at Biogen as the Director of Global Stability and also as a Global Regulatory CMC lead. Before joining Biogen, he was in charge of Process Validation for the Pfizer, Sanford, NC site. He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor & Francis]. Dr. Nunnally has authored numerous publications in the field of analytical chemistry and operational excellence. He is a member of the CASSS Board of Directors. received two B.S. degrees (1994) from South Carolina Honors College, University of South Carolina, Columbia, and a Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina. Prior to taking the Process Validation position, Dr. Nunnally worked in TO&PS Regulatory Affairs. He was responsible for leading the Sanford site's contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&PS Regulatory, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all Reference Standards, Stability, GMP Testing, and Validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a Quality Control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Karen Ginsbury shares her ideas on data integrity lapses, and how automating now can save your business in the future. Karen looks at how the pharmaceutical industry and even society misunderstand what integration truly is. Karen shares her thoughts on how the industry can advance forward despite self-inflicted obstacles.
About Our Guest:
Karen Ginsbury is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Chinmoy Roy to answer some important questions about the current state of digital transformation across the pharmaceutical industry. Digital transformation in the pharmaceutical industry is crucial for better patient care, cost-effectiveness, greater transparency, improved production, and drug development. Across the pharmaceutical industry, companies are at varying stages in the adoption of digital technologies, but it is clear that the recent COVID pandemic may have accelerated this process for all by about 3 to 4 years. So where are we now as an industry, and what are companies doing to move toward a strategic digital transformation plan?
About Our Guest:
Chinmoy Roy is a seasoned Life Sciences professional with 40 years of hands-on and managerial experience in the life sciences industry. He brings extensive implementation experience in engineering, CCSV (Computerized and Cloud Systems Validation), Data Integrity, and IT compliance, providing the foundation for his consulting and training services. His training in CCSV and Data Integrity has been meticulously developed to disseminate the understanding of industry regulations from fundamental principles of science, engineering, and technology. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu's annual conference for the Asia Pacific, etc. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson, etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training. He was one of the early implementors of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech was a precursor to the FDA's issuance of Part 11's Scope and Application guidance in 2003.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Welcome to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
In this week's episode, we look back at some interesting discussions from the first year in our Risk Revolution series. In these clips, you will hear from series coordinator Nuala Calnan, series regular Lori Richter, Chris Flask, Valerie Mulholland, Amanda McFarland, Rob De La Espriella, and Marty Lipa.
Segment 1 (00:00): The first clip is taken from episode one in the series and features a discussion on the current challenges of QRM.
Segment 2 (07:30): The second clip is taken from the episode "Making Confident Risk-Based Decisions". In this clip, Lori will help define what Risk-Based decisions truly are.
Segment 3 (15:33): This segment is taken from "Dreading The Risk Life". Amanda McFarland discusses what and why risk can be a dreadful thought for many in the industry.
Segment 4 (20:03): This segment, from the "Getting to the Root of the Matter" episode, looks at complex problem solving with guest Rob De La Espriella.
Segment 5 (30:45): Finally we hear from Marty Lipa about why QRM and KM ended up as separate processes in the industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Kelly Simpliciano hosts a discussion on GXP inspection principles and the changes in processes and expectations stemming from the Covid-19 pandemic. More work than ever is being completed by virtual connections, remote activities, and through systems and processes more reliant on collaborative team efforts and digital technologies. Understanding how these elements affect our inspection preparedness, as well as our day-of-audit activities, is critical to a successful site visit. Be prepared for virtual site visits and audits to become the norm.
About Our Guest:
Kelly Simpliciano
Associate Director, Research Development Quality - Clinical Trials Systems & Auditing QA Bristol-Myers Squibb. Kelly has been with Bristol-Myers Squibb since 2003 when she joined as a QA analyst. Kelly achieved her MS, Quality Assurance and Regulatory Affairs in 2018.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This episode is brought to you by IVT Network's Validation Week.
This week, Ferdi Steinmann shares his three things you can do to bring intelligence into everything you do. Ferdi breaks down the barriers to intelligence and helps show the path to overcoming the tsunami of data in life sciences. Ferdi covers medical innovations, patient applications, wearables, and the internet of medical things.
About Our Guest:
Ferdi has nearly 25 years of driving strategy & commercialization efforts in Biotech, Pharma, and Enterprise Software with Fortune 500 Co’s such as Merck & Co, Eli Lilly & Biogen. Ferdi’s focus is on Life Sciences (LS) strategic planning and industry marketing efforts for enterprise software solutions at OpenText today. He is energized by strategies that deliver on their promises!
www.opentext.com
www.ivtnetwork.com
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Alan Golden hosts a comprehensive discussion on the changes driven by risk and conversely risk updates that are driven by change as well as risk integration. Alan will share his expertise from over 30 years in the medical device industry.
Alan Golden: Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management, and process/test method validation. Alan has more than 30 years of experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This episode is brought to you by IVT Network's Validation Week.
In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the book "Foundations in Quality Risk Management" with the author, Dr. Tim Sandle. One of the key topics of discussion is dealing with "Fuzzy Logic", and how to manage situations that appear vague, and how that applies to the Pharmaceutical and Healthcare industries.
Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
Resources from this episode:
- The ICH Q9 (R1) Guidelines
- ICH Q9 (R1) Presentation
- Can Fuzzy Logic Be Applied to Risk Management
- Critical Thinking #1: Why Pharmaceuticals and Healthcare Needs ...
- Critical Thinking #2: Reading Research Papers
- Critical Thinking #3: Developing Questions to Achieve the Optimal ...
- Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution
- Risk Revolution - Getting to the Root of the Matter
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Alex Castro to talk about accepting that bias does exist, and strategies for managing and moving beyond biased decision-making practices. Biases is a very interesting topic, and one that we take very seriously in life science manufacturing, as it can impact the quality of the product and add undue risk in this highly regulated environment. Interestingly, many do not consider their personal biases and their impacts on our decision-making and general ways of thinking.
About Our Guest:
Alex Castro
Alex Castro is an aligner of execution to strategy for digital transformation & innovation, best-selling author, and creator/founder of ReM Score™. Alex believes that the gap between ideas (strategy) and execution is a persistent problem that is sidelining too many high-potential digital transformation and innovation growth opportunities.
What will set companies apart in these uncertain economic times are those that reduce the falloff rate of good ideas during execution, seeing more of them create value, resulting in ultimately thriving in the ‘next normal.’
Aligning execution to your ideas for digital transformation and innovation is rooted in removing the biases that have us repeating the same errors in estimating our capabilities to execute.
There is a way to calculate your execution capability for each idea you have, so more of them come to life, and you and your company win more. Alex is a charismatic, intelligent, and knowledgeable guest, with plenty of wisdom to share.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined once again by Chris Wubbolt. Stacey and Chris discuss the ins and outs of paper vs. electronic records. In GMP-regulated environments maintaining proper records and documentation is critical to data integrity, regulatory compliance, and GMP best practices. Starting with Part 11 more than two decades ago, we’ve seen an emphasis on good record keeping and a shift to paperless. Still, paper-based systems are prevalent around the world, but given our current environment and reliance on digital technologies are we now at a point where the industry is ready to embrace that shift?
About our guest:
Chris Wubbolt
Chris has over 25 years of experience in the regulated industry and has provided compliance, quality assurance, and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey chats with Rich Forsyth about understanding how the results of testing, and reproducibility of test results under varying conditions allows for consistency across teams and lessens the risk of error in cleaning validation activities. Visual inspection of equipment has always been an important element of the cleaning validation program. Establishing visible residue limits is extremely valuable in setting a baseline for cleanliness, highlighting viewing conditions, and defining a methodology for performing routine checks on cleaning validation procedures.
Resources for this episode:
- Richard J. Forsyth; Ruggedness of Visible Residue Limits for Cleaning Validation, April 2, 2016, Pharmaceutical Technology
- FDA Cleaning Validation Guideline from CFR 211.67
- Questions and Answers on Current Good Manufacturing Practices—Equipment
- EMA Cleaning Validation Guideline on setting HBELs
- QnA on the implementation of the above guideline
- WHO good manufacturing practices for active pharmaceutical ingredients
- Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation
- PIC/s Aide-Memoire: Inspection of Health Based Exposure Limit (HBEL) Assessment and use in Quality Risk Management
- Health Canada Cleaning Validation Guideline
About our guest:
Richard Forsyth
Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey presents the 2021 IVT Awards and interviews the recipients of each award. The awards being presented are Author of the Year for the Journal of GXP Compliance, Author of the Year for the Journal of Validation Technology, Podcast of the Year, Speaker of the Year for Validation Week, Speaker of the Year for Compounding Pharmacy Compliance, Speaker of the Year for Computer Systems Validation and Software Assurance, and the prestigious Chapman Award.
During this presentation, you will hear from Ron Schardong, Valarie King-Bailey, Richard Wedlich, Kurt Moyer, Steve Thompson, Dr. Ross Caputo, and Dr. Paul Pluta.
The team at IVT Network, together with our Esteemed Advisory Board, are proud to announce the recipients of the 2021 IVT Awards. These annual awards recognize the outstanding authors, speakers, podcast guests, and presenters, who keep our audience informed and forward-thinking.
Nominees for the author of the year (both JVT and GXP) are selected by their peers, based on articles published and topics covered, which have been integral to learning and knowledge share across industries throughout the year. The podcast of the year is presented to the individual or panel receiving the greatest number of downloads and listens. Finally, our speakers of the year are selected by vote from attendees of the sessions as the most impactful and engaging in their presentations for the associated event.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey and Nuala sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable.” Jayet will also explain how lobsters can live forever.
Resources from this episode:
- A Quantitative Method for Modelling
- Copy of SAQI eQE Newsletter Issue 241 - February 2021
- Copy of Quality World - Spring 2021
- Foundations Of Quality Risk Management: A Practical Approach to Effective Risk-Based Thinking
About our guest:
Jayet Moon
Jayet has earned a master’s degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). Jayet is also a Chartered Quality Professional in the UK certified by the Chartered Quality Institute (CQI). He is also an Enterprise Risk Management Certified Professional (ERMCP) and a Risk Management Society (RIMS) certified Risk Management Professional (RIMS-CRMP). Jayet was recently awarded the Australian Organization for Quality 'Passion for Excellence' Award and recognized as American Society for Quality '40 under 40' Rising Star in their November 2021 issue of Quality Progress magazine. He is a Fellow of Royal Society for Arts (FRSA) and a Fellow of International Institute for Safety and Risk Management (FIIRSM). He is the author of the book, ‘Foundations of Quality Risk Management’ published by ASQ Quality Press, and holds ASQ CQE, CQSP, and CQIA certifications. Popular articles authored by him on Quality and Risk Management have been published in global trade magazines such as Quality Press (USA), Quality World (UK), Quality Business (Australia and New Zealand), QCI Magazine (India), and eQuality Edge (South Africa).
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Kate Coleman to discuss the essentials for building a culture of quality while achieving customer satisfaction. Across life sciences, teams concur that quality, defined by safe, effective, and compliant products, is a prerequisite of the pharmaceutical, biomedical or medical device industry. The Quality Management System then provides the basic infrastructure needed for defining and validating the documents, processes, procedures, and systems to meet the company's quality objectives. The bi-product? ̶ the highest customer and patient satisfaction.
Resources from this episode:
Overview of the Quality System Regulation - US Food and Drug
Guidance for Industry Q10 Pharmaceutical Quality System
Can a robust QMS help you achieve customer satisfaction?
About Our Guest:
Kate Coleman, Senior Director/ Principal Consultant at PharmaLex
Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor, and an SME in Risk Management, New Facility Design/Start-Up, QC, and Sterility Assurance.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk-based monitoring (RBM) approach may be the best method to support clinical studies while keeping an eye on compliance.
Resources from this episode:
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring - Guidance for Industry (2013)
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers - Draft Guidance for Industry (2019)
Tackling the Challenges of Transitioning to Risk-Based Monitoring
About Our Guest:
Amanda Coogan, Senior Customer Partnership Manager, Remarque Systems Amanda spent the first 12 years of her clinical research career in clinical operations for university hospitals and medical device firms supporting domestic and international studies. She then transitioned to the software industry, where she has served for 6 years as a consultant, subject matter expert, and project manager to small and large pharma, medical device, and CRO customers supporting their implementation of Risk-Based Quality Management. In addition to working with customers to optimize their use of technology within their RBQM strategy, she provides clinical trial operation expertise to support software product development. She can be reached at acoogan@remarquesystems.com
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Bryan Prince to talk about the implementation of the 2019 final version of USP 800, and how it is not currently being enforced by most states but quite a few pharmacies around the country are either in the planning and budgeting phase or have already moved forward with construction and being compliant with USP 800 standards.
Resources from this episode:
USP General Chapter Hazardous Drugs regulations
Physical Environment Provisions of USP
About our guest:
Bryan Prince is the owner and lead consultant at Lab Red Pharmacy Consultants. His early career consisted of more than a decade in construction before moving to engineered containment serving the pharmaceutical industry and now the compounding industry. Since 2015 Bryan has designed and consulted on more than a hundred compounding pharmacies working with owners, architects, engineers, and contractors.
Email: bryan@compoundingworkflow.com and watch videos http://compoundingworkflow.com
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more.
Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
Resources from this episode:
QRM: a Case for Convergence
Risk-Based Decision Making: PODCAST RECORDING
Risk Management, Knowledge Management, and the Risk
Understanding the Concept of Formality In Quality Risk
Quality Management Maturity – A Pilot Program of the FDA
ICH Q9 R1 concept document
ICH Q14 Concept Paper
2021 Updated PIC/s Aide-Memoire on Assessment of QRM Implementation
Sept 24, 2021, Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle
About Our Guest: Valerie Mulholland Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey and industry expert, Chris Wubbolt, count down the top five data integrity issues when complying with GMP guidance. Data Integrity is a critical element to GMP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and stored properly. Of course, this is all part of the Regulatory Guidelines which have been in place for years. Still, nearly half of all warning letters contain data integrity components.
Resources for this Episode:
Data Integrity and Compliance with cGMP Guidance
Guideline on data integrity - WHO | World Health Organization
Part 11, Electronic Records; Electronic Signatures - Scope and Application
About Our Guest:
Chris Wubbolt, Principal, QACV Consulting
Chris has over 25 years of experience in the regulated industry and has provided compliance, quality assurance, and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other areas of drug manufacture, there is an expected dedication to quality and compliance, which should be present in every aspect of distribution. It is the responsibility of the drug company to comply with distribution requirements including storage and transport of their products, ensuring its safety and security throughout the supply chain.
About Our Guest:
Siegfried Schmitt
Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems, including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity, and Supply Chain, as well as a trusted expert for regulatory, compliance, and industry-best-practices projects. Siegfried has more than 30 years of experience in the healthcare industry, spanning manufacture, analytics, validation, and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland, and is a Fellow of the Royal Society of Chemistry.
For more information or to register for the Compounding Pharmacy Compliance East conference, please visit: https://bit.ly/3yzhlnN
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What’s better left to understand is the if’s and how’s around adoption and implementation within our own organizations. A risk-based approach is nothing new. However, the evolution centers on a risk-based approach using critical thinking, with a focus on assurance needs, testing activities for our higher-risk activities.
About our Guest Ken Shitamoto, MS
Senor Director, IT, Gilead Sciences
Ken leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus shut down of equipment between “batches” is required, which eliminates downtime. CM saves time and reduces the likelihood of human error, but is it realistic at this point in time?
Resources for this episode:
FDA issued draft guidance, Quality Considerations for Continuous Manufacturing
Rogers, Luke & Jensen, Klavs F. (2019). Continuous manufacturing – the Green Chemistry promise?. The Royal Society of Chemistry. Green Chem., Volume 21, 3481-3498.
Moore, Christine M. V., Garcia, Thomas P., Hausner, Douglas B., Ben-Anat, Inna. (2019) Holistic Control Strategies for Continuous Manufacturing. Pharmaceutical Engineering, May/June 2019
Srai, Jagjit Singh., Settani, Ettore., Aulakh, Parminder Kaur., Evaluating the Business Case for Continuous Manufacturing of Pharmaceuticals: A Supply Network Perspective. Continuous Pharmaceutical Processing, June 2020, 477-512
Van Arnum, Patricia. Pharma Industry Weighs in on Continuous Manufacturing. June 19, 2019
Manning, Richard., Sciacca, Rich., Continuous Manufacturing in Pharmaceuticals: Economic and Policy Issues. Bates White Economic Consulting, October 2018
About Our Guest:
Renée L. Phillips is an Associate Director of Global Regulatory Affairs at Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson. Renée has responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in Regulatory Affairs at Johnson & Johnson Consumer Companies, Wyeth Consumer Products, a small start-up pharma company, and an environmental chemistry laboratory. Renée currently serves as an adjunct professor at Temple University School of Pharmacy where she teaches courses in good manufacturing practices and global drug registration requirements. She earned her Bachelor of Science in Biochemistry from Georgian Court College and a Master of Science in Regulatory Affairs from San Diego State University.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.
Resources from this episode:
One Voice of Quality Website
One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT
One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ...
Elon Musk Hiring Ad
What Is Industry 4.0?
About Our Guest: Karen Ginsbury Karen is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by David Nettleton to discuss some of the key topics from the recent CSV Virtual Week panel "CSA Revolution." The session "CSA Revolution" was intended to provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing regulations. David will share his expertise on some of the ideas and concepts shared in the discussion.
About Our Guest:
David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. He can be reached at dnettleton@computersystemvalidation.com
For information or to register for Validation Week 2001 visit: VALIDATION WEEK 2021
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, we will hear an exclusive panel discussion CSV Virtual Event "CSA Revolution." This discussion will provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing regulations. Key concepts of CSA include the push for critical thinking and risk-based principles as part of the lifecycle strategy in support of data integrity, and how CSA promotes better use of data for the benefit of patient safety and product quality.
The panelists for this discussion:
Senthil Gurumoorthi - Director IT Gilead Sciences
Cisco Vicenty - Program Manager Case for Quality FDA
Ray Murphy - Principal Engineer Corporate Software Quality Boston Scientific
Ken Shitamoto - Senior Director IT Gilead Sciences
Khaled Moussally - EVP Clients & Regulatory Relations Compliance Group Inc.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Divya Yerraguntla to host a panel discussion on Women in STEM, in partnership with the Woman to Woman podcast. On this panel you will hear conversations about developing an interest in STEM, overcoming barriers in the pursuit of an education in STEM, the obstacles women face when beginning their careers and advancing their careers. The panel takes a look at women's evolving role in STEM and what the future may hold.
The panelists on this episode are Erin Russell, Valarie King-Bailey, Barkha Saxena, and Beth Kroeger.
About the panelists:
Divya Yerraguntla
Divya is the host of the Woman to Woman podcast. Divya is also the Vice President, Asset Strategy for Syneos Health. Divya graduated from the Indian Institute of Technology with a Masters in Applied Mathematics. She completed her MBA in Marketing and Strategic Management from Rutgers University.
Barkha Saxena
Barkha is currently the Chief Data Officer for Poshmark. Barkha also serves on the Board of Advisors for Pecan AI. Barkha graduated from the Indian Institute of Technology with a BS and MS in Statistics. She also graduated from the University of California at Santa Barbara with a MA in Statistics and completed her MBA in Strategic Management from The Wharton School.
Beth Kroeger
Beth is a Technical Service Manager. She specializes in cleaning chemistries, processes, and validation. Beth’s background includes over 18 years of experience in finished pharmaceutical and upstream and downstream biotech manufacturing. Beth has a B.S. in Biochemistry.
Erin Russell
Erin is the Founder and CEO of Health Grizzly, a wellness and care navigator helping people find the care they need to improve their health. Erin graduated from Arizona University with a BS in Chemistry. Erin completed her MBA at Harvard Business School.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this week's edition of Risk Revolution, Stacey is joined by Nuala Calnan and Marty Lipa to discuss the Risk Knowledge Infinity Cycle. Stacey, Nuala, and Marty also chat about the ways Risk Management and Knowledge Management work together to provide a more effective Quality Management System and the two enablers to building an effective Quality Management System, QRM and KM, which really have been kept separate in the industry but should be working together.
Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.
Resources from this episode:
ISPE’s KM Good Practice Guide
T.U. Dublin’s : A Survey Report on the Current State of QRM and KM Integration
Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge Managemen
Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers
Effective Knowledge Transfer During Biopharmaceutical Technology Transfer
Turning Knowledge Into an Asset in Pharmaceuticals – PODCAST
About Our Guest:
Marty Lipa
Marty Lipa, is the Executive Director - Knowledge Management at Merck. Marty has over 27 years in the biopharmaceutical industry and has led the KM Center of Excellence for Merck manufacturing for the last 11 years. Marty has recently completed the requirements for his Ph.D. at TU Dublin with an emphasis KM and its connection to QRM.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Dr. Tim Sandle to discuss developing effective contamination control strategies to deal with all aspects of contamination such as particulate, microbial, product carryover, chemical (like cleaning material residues) as well as viral. Dr. Tim Sandle details the common types of contamination, what regulators are seeking from control strategies, the challenges of implementing control strategies, and much more.
Resources for this Episode:
Biocontamination Control for Pharmaceuticals and Healthcare, by Tim Sandle
EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft)
ISO 14698-1: 2003, Cleanrooms and associated controlled environments
FDA Guidelines on Contamination Control
Sterile Drug Products Produced by Aseptic Processing
〈797〉 Pharmaceutical Compounding—Sterile ... - USP
About Our Guest:
Dr. Tim Sandle Ph.D. is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. Dr. Sandle currently works for an international sterile products manufacturer and he is additionally a visiting tutor with the University of Manchester (lecturing in pharmaceutical microbiology), a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig), and a supporter of several other societies relating to pharmaceuticals and healthcare, including IVT. Dr. Sandle also serves on several advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, 125 peer-reviewed papers, and some 400 technical articles. Dr. Sandle is a regular presenter at conferences and webinars, having delivered over 150 presentations.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Steve Thompson to discuss some of the key topics from the recent CSV panel on "Digital Transformation Initiative." The panel shared first-hand experiences of point solutions, and platform transitions, as well as lessons learned from migration to cloud computing and cloud first approaches. Steve will share his expertise on some of the ideas and concepts shared in the discussion.
About Our Guest:
Steve Thompson has over 20 years of experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies, including biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003 and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986. He can be reached at steven.thompson@valgenesis.com
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Digital Transformation Initiative" This discussion was moderated by Daniel Matlis and features Sam Cheemokati, Paul Hurlocker, and Ron Schardong.
The discussion will be focused on exploring organization-wide digital transformation initiatives. The panel will share their firsthand experiences of point solutions to platforms transitions. And, the best practices when shifting to cloud computing and the cloud-first approach.
About the panel:
Daniel Matlis
Daniel R. Matlis is the Founder and President of Axendia – a trusted advisor to Life-Science and Healthcare executives on business, technology, and regulatory issues.
Dan’s career in the industry spans over 20-years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.
Prior to founding Axendia, Dan was General Manager & VP at Stelex (now a GE company) – a leading consultancy to life-science companies.
He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.
Sam Cheemakoti
Sam is the GMP Head at Beiersdorf for the Coppertone Division overseeing GMP compliance of its computer and automated systems. Sam has held positions of increasing responsibility at various Pharmaceutical companies such as Bayer, Merck, and Schering Plough in the areas of Computer Systems Validation, IT Compliance, and Quality Assurance. As a Quality leader with 20+ years in the industry with a demonstrated ability to produce and deploy Part 11 and Data Integrity remediation programs, validation programs, quality systems, strategic initiatives for Quality and Compliance especially under conditions of the consent decree, acquisitions, and divestitures has lent him unique perspectives as a change ambassador and thought leader. Sam earned his MS in Industrial Engineering from Louisiana Tech University and his Project Management credentials from Villanova University. He more recently completed a course on Digital Transformation: Leading People, Data and Technology from the University of Berkeley under their Executive Education Program in order to gain synergies between the two journeys of Digital Transformation and Computer Software Assurance for Quality.
Paul Hurlocker
Paul is the CTO at Spring Oaks Capital, a technology-driven financial services company whose mission is to reinvent the debt recovery industry by providing a customer-centered user experience and streamlined operations powered by data and machine learning. Paul previously served as the Senior Director and Vice President of the Center for Machine Learning for Capital One. Paul founded Notch, Co and served as the CEO before selling the company to Capital One.
Ron Schardong
Ron is privileged to lead Johnson & Johnson’s Technology Quality group responsible for computerized systems validation of business applications in the Medical Devices, Consumer, and Pharmaceutical segments worldwide. The applications include ERP, Warehouse Management, Manufacturing, Laboratory, Quality Systems, Clinical, R&D, Enterprise Tools, Services, and Infrastructure. He has over 25 years of experience in quality engineering, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of FICSA Group (FDA + Industry Computer Assurance Group).
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Robin Toft to talk about the challenges of attracting and hiring top talent, tactics for building and retaining a workforce, and the technologies that are changing the ways we recruit, hire, and train our teams. Stacey and Robin also discuss which areas are in the most demand, talent management strategies, career path planning, and much more.
Resources from this episode:
Talent 2020: Surveying The Talent Paradox From The Employee Perspective: The View From The Life Sciences Sector https://www2.deloitte.com/content/dam/Deloitte/mx/Documents/human-capital/Talent_2020_LifeSciences.pdf
WE CAN: The Executive Woman's Guide to Career – on Amazon https://www.amazon.com/WE-CAN-Executive-Womans-Advancement/dp/1949635031
WE CAN: The Executive Woman's Guide to Career – on Goodreads https://www.goodreads.com/book/show/43533323-we-can
We Can Rise Community https://wecanrisecommunity.com/
About Our Guest:
Robin Toft is the founder and CEO of Toft Group a ZRG Company, where she combines a deep inside knowledge of the life science industry with a passion for building game-changing management teams. A champion of diverse executive teams, Robin has built a reputation for recruiting women and minorities into top roles and helping the life science industry overcome unconscious bias in hiring. Having successfully sold Toft Group to ZRG Partners, Robin co-founded We Can Rise in 2020, a B-corporation aimed at helping aspiring female executives to confidently reach their potential while achieving balance and collaborating to build healthier companies that change the world. Prior to founding Toft Group in 2010, Robin served 20+ years as a biotech executive. Robin’s first book entitled WE CAN, The Executive Woman’s Guide to Career Advancement, is recognized within the list of 100 Best CEO Books of All Time by BookAuthority and won Gold for Best E-book in the International Business Awards. In the American Business Awards for 2020, Robin won Gold in the three major individual categories of Lifetime Achievement, Maverick of the Year, and Woman of the Year. She also won Gold for Most Innovative Woman of the Year in the Women in Business Awards for 2020.
Robin currently serves on the boards of T2 Biosystems, Syapse, California Life Science Association (CLSA), The Clearity Foundation, and LEAD San Diego. Robin holds a B.S. in Medical Technology from Michigan State. Voices in Validation brings you the best in validation and compliance topics.
Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to actually living a work-life and culture that embraces risk management?
Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.
Resources from this episode:
12 Inclusive Behaviors - The Kaleel Jamison Consulting
How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis
Amy Edmondson – TED TALK, Psychological Safety
About Our Guest:
Amanda McFarland - Senior Consultant at Valsource
Amanda assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. Amanda specializes in creating and implementing risk management training programs, developing custom risk-based strategies, and risk facilitation.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Valarie King-Bailey to discuss some of the key topics from the recent CSV panel on "Excellence and Next-Generation Approaches to Quality System Monitoring." The panel provided reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control. Valarie will share his perspective on these topics as an industry expert.
About our Guest Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products, and solutions. OnShore’s product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market. ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. At QUMAS, an Irish-based software company, she served as Chief Marketing Officer. She was responsible for all global tactical and strategic marketing initiatives and the development of their validation toolkit. Valarie founded OnShore Technology Group in 2004. OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008). She also received a nomination for the Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from Wisconsin–M Madison (1982). She is a member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society (RAPS), and a U.W. College of Civil Engineering Advisory Board Member. She can be reached at vkbailey@onshoretech.com
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Excellence and Next-Generation Approaches to Quality System Monitoring." This discussion was moderated by Michelle Miller and features Nuala Calnan, Alyce Deegan, and Daniel Caparros.
The discussion will be focused on providing reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control.
About the panel:
Michelle Miller
Michelle Miller is Director of Global Validation at Illumina Inc. In this role, Michelle leads the global non-product validation across the company. This includes the strategy and execution of validation for facilities, manufacturing processes, consumables production, quality system, enterprise software, and other systems across all of Illumina. Over the past 12+ years, she has held roles in product engineering, product transfer, validation engineering, and quality assurance, supporting the manufacturing of microarrays, genome sequencing reagents, and consumables.
Nuala Calnan
Nuala is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality.
Nuala works with organizations to transform organizational culture, deliver more effective end-to-end risk management, implement knowledge excellence strategies, behavior-based good data governance, and enhance performance management through people.
Nuala co-leads the ISPE Quality Culture Team, is a founding member of the ISPE Knowledge Management Task Team, and an Arnold F. Graves Scholar at TU Dublin, Ireland, where she leads many patient-focused regulatory science research projects at Masters and Ph.D. level.
Alyce Deegan
Alyce has over 20 years of experience in the Pharmaceutical, Medical Device, and Gene Therapy industries. Alyce recently was the CSV Director at SeaGen and the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA. Throughout Alyce’s career, she has held leadership positions in Quality, Validation, and IT at Pfizer, Biogen, and ThermoFisher.
Daniel Caparros
Head of Global Quality Strategy Data and Vendor Management at Merck KGaA, Darmstadt, Germany
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them.
Resources from this episode:
Pharmaceutical Quality for the 21st-century report
Quality Management Maturity Pilot Program as announced by the FDA
About Our Guests:
CDR Lyle Canida CDR Lyle Canida is a PHS officer with 11 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA, he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing post-market safety programs for drugs, foods, cosmetics, and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other strategic initiatives.
Jennifer Maguire, Ph.D. Dr. Jennifer Maguire is the Deputy Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including QbR, QbD, ICH Q12, Site Selection Model, Quality Metrics, and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a Ph.D. in Industrial and Physical Pharmacy from Purdue University.
Nandini Rakala, Ph.D. Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master’s degree in Applied Mathematics and Computing from Manipal University, India; and a bachelor’s degree in Mathematics Honors from the Sri Sathya Sai Institute of Higher Learning, India. During her past 2.5 years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ pilot programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of PQS-CAPA effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on several occasions at various conference seminars, and she is a recipient of numerous prestigious awards. In her personal free time, Nandini enjoys volunteering in community service activities, serving as a judge, playing tennis, writing, reading articles, and biographies.
Alex Viehmann Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance. The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment. Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control. He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions. Since joining OQS in 2015, Alex has guided the development of OPQ’s Quality Metrics program, CDER/ORA’s New Inspection Protocol Project (NIPP), and OQS’s analytics and modeling program. He is also actively engaged in implementing Pharmaceutical Quality System (PQS) assessments in support of Established Conditions and the Site Engagement Program (SEP). He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management. Alex received his bachelor’s degree in economics from the University of Maryland at College Park.
Carla Lundi Carla J. Lundi has been with the FDA as a Consumer Safety Officer since 2002, working initially with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016 she transferred to CDER’s Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug product and manufacturing site quality-related signals for mitigation of urgent quality issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal and external customers; collaborating with business partners to determine data to be collected from sites through onsite inspections or other innovative approaches; and drug training collaboration and development.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource.
Resources in this episode:
Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein
The Surprising Power of Questions HBR
Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT
Bias, Heuristics & Risk (Pt. 2) on Risk Revolution | IVT
About Our Speakers
Lori Richter
Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx, she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada, and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a Ph.D. at Technological University Dublin.
Nuala Calnan –
Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient-focused regulatory science research projects at the Masters and Ph.D. levels.
Tiff Baker –
Tiff Baker, is a Senior Consultant at Valsource. Tiff has been working full time in the QRM space for over ten years, and in micro roles within the industry prior to that. She has implemented QRM programs for companies internationally, delivered risk training to industry and regulators alike, developed custom risk tools to meet client needs, and facilitated many risk assessments over the years. She is a co-lead for the Parenteral Drug Association’s Remote Audits and Inspections Task Force as well as an instructor for the PDA Training and Research Institute. In addition, Tiff contributed as an author to ISPE’s Baseline Guide 5 for Commissioning and Qualification to incorporate risk as well as several Points to Consider documents for the PDA.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Paul Pluta and Karen Zimm to discuss the particulars of the drug naming process, definitions, and categories for drug names. Karen and Paul present case study scenarios where drug name communications have led to adverse events.
A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it’s look alike or sound alike errors, drug modifier misidentification, or proprietary vs. non-proprietary names, confusion may lead to medication errors – which of course can have fatal effects on patients and consumers.
Resources for this Episode: Articles:
- Medication Safety: Industry Considerations Part 1 - Problem Overview https://www.ivtnetwork.com/article/medication-safety-industry-considerations-part-1-problem-overview
- Regulatory 101: Medication Safety - Industry Considerations, Part 2, Drug Names https://www.ivtnetwork.com/article/regulatory-101-medication-safety-industry-considerations-part-2-drug-names
- Regulatory 101: Drug Name Modifiers – Definition, Categories, Generics, And CAPA https://www.ivtnetwork.com/article/regulatory-101-drug-name-modifiers-%E2%80%93-definition-categories-generics-and-capa
- Regulatory 101: Biologic Non-Proprietary Drug Names – Terminology And Format https://www.ivtnetwork.com/article/regulatory-101-biologic-non-proprietary-drug-names-%E2%80%93-terminology-and-format
- Medication Safety And Drug Names - Valproic Acid Product Problems https://www.ivtnetwork.com/article/medication-safety-and-drug-names-valproic-acid-product-problems
References:
- FDA. Guidance for Industry. Best Practices in Developing Proprietary Names for Drugs. https://www.fda.gov/media/88496/download
- FDA. Contents of a Complete Submission for the Evaluation of Proprietary Names. https://www.fda.gov/media/72144/download
- FDA. Safety Considerations for Product Design to Minimize Medication Errors. https://www.fda.gov/media/84903/download
- FDA. Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. https://www.fda.gov/media/85879/download
- Medicines & Healthcare products Regulatory Agency (UK MHRA). MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/810914/MHRA_Guideline_for_the_Naming_of_Medicinal_Products_and_Braille_Requirements_for_Name_on_Label.pdf.%C2%A0
- European Medicines Agency (EMA). Guideline on the acceptability of names for human medicinal products processed through the centralized procedure. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf.
- Health Canada. Guidance Document for Industry. Review of Drug Brand Names. https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-review-drug-brand-names.html
- Health Product Regulatory Authority (Ireland). Guide to Invented Names of Human Medicines. file:///D:/HPRA%20Drug%20names.pdf.
- To Err is Human: Building a Safer Health System. Institute of Medicine, National Academic Press, Washington, DC, 2000. https://www.ncbi.nlm.nih.gov/books/NBK225182
- Preventing Medication Errors. Institute of Medicine. National Academic Press., Washington, DC, 2007. https://www.nap.edu/catalog/11623/preventing-medication-errors
Karen R. Zimm, Ph.D. Karen is currently an Associate Director in Global Regulatory Affairs for Johnson & Johnson Pharmaceutical Research and Development with responsibility for Chemistry Manufacturing & Controls for API’s and marketed products. Previously she has held positions in technical operations with Pharmaceutical Sourcing Group – Americas, a division of Ortho-McNeil Pharmaceutical and research & development for the R.W. Johnson Pharmaceutical Research Institute and Whitehall Robins Healthcare (Wyeth Consumer Products). She earned her Bachelor of Science in Pharmacy and PhD in Pharmaceutics under Dr Joseph Schwartz from the Philadelphia College of Pharmacy and Science, MBA in Pharmaceutical Management from Drexel University, and the MS in Quality Assurance/Regulatory Affairs from Temple University. In addition she is a licensed pharmacist and an adjunct professor for the School of Pharmacy/Quality Assurance-Regulatory Affairs at Temple University in Philadelphia, PA.
Paul L. Pluta, Ph.D. Paul is a pharmaceutical scientist with technical development, manufacturing, and management experience. He has been involved in nearly all phases of pharmaceutical development and manufacturing including R&D formulation and process development, dissolution, stability, regulatory, quality assurance/control, compliance, specifications, scale-up, technology transfer, technical support, and validation/qualification. In his time at Abbott he had numerous new product and supporting regulatory submissions, as well as, extensive product technical support experience. Additionally, his validation experience includes manufacturing process validation, cleaning validation, and associated systems qualification including aseptic systems. He was also a practicing pharmacist for many years in community and hospital environments with direct involvement in preventing medication errors. He may be reached at paul.pluta@comcast.net.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Roberta Goode, who will moderate a discussion on Combination Product Development and some of the challenges that arise in the process. Stacey and Roberta are joined by panelists Becky Leibowitz from Janssen, Kurt Moyer from Pine Lake Laboratories, and Alan Golden from Design Quality Consultants.
Resource from this episode:
EU Medical Device General Safety and Performance Guidance – MDR
ANNEX 1 Guidance
FDA 21 CFR Part 4 – Subpart A – Current GMP for Combo Products
FDA 21 CFR Part 4 – Subpart B Post-marketing Safety Reporting for Combo Products
ICH Q9 QRM Guidance
ISO 10993 – 2018
ISO 11607 Sterile Barrier
ABOUT OUR GUESTS: ROBERTA GOODE - Moderator Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International, a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control and risk management. Prior to founding GCI’s medical device division in 1993, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson and Johnson company), where she contributed intellectual property in the form of four US patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.
ALAN GOLDEN – Panelist Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years’ experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018. He can be reached at alangolden.dqc@gmail.com
BECKY LEIBOWITZ - Panelist Becky Leibowitz is Director of CMC Regulatory Affairs at Janssen and leads a team of regulatory professionals responsible for developing innovative CMC regulatory strategies for global drug-device combination product clinical trial and marketing applications. At Janssen, Becky has been responsible for the device-specific sections of US and ROW regulatory submissions for single entity and co-packaged combination products, for new products in development and for post-approval changes. Prior to Janssen, Becky developed biologic-device combination products and medical devices at ETHICON. Becky holds both a BS and PhD in Mechanical Engineering.
KURT L. MOYER – Panelist Kurt L. Moyer, Ph.D. is currently the President of Pine Lake Laboratories and was the General Manager of Pine Lake Laboratories predecessor NSF Health Sciences for over 10 years. Prior to joining NSF Health Sciences, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University. He may be contacted at kmoyer@pinelakelabs.com or at 860-940-6550. He can be reached at kmoyer@pinelakelabs.com
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey welcomes back Ivan Soto to discuss how the pandemic has impacted all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. Downtime due to social distancing requirements, employee illness, and the close of many departments for on-site purposes have had a major impact on productivity and production. Although most companies in the industry have Business Continuity Plans, most of them were not detailed or inclusive enough to provide contingencies for all impacted functional areas. Today we will highlight strategies that enable validation leadership and teams to keep validation activities functional and productive not only throughout but following the pandemic.
Resources from this episode:
Keeping Validation Functional & Productive During A Pandemic - Article in Journal of Validation Technology, Vol. 26, Issue 6, December 2020
Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts - Article in Journal of Validation Technology, Vol. 26, Issue 4, August 2020
Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and has held several technical and management positions at different biotech and pharmaceutical companies in Validation, IT Compliance, Quality Control, Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.
This week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures.
Resources from this episode:
Root Cause Analysis – A Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach
Addressing the Root Cause, Not the Symptoms: Root Cause Investigations for CAPA – Podcast - https://www.ivtnetwork.com/article/addressing-root-cause-not-symptoms-root-cause-investigations-capa
Getting to the Root of the Cause – BioPharm International article - http://www.ivtnetwork.com/sites/default/files/PRE PUB__BP0521_Getting to the root of the matter.pdf
Rob De La Espriella is a former nuclear submarine officer and the founder/owner of DLE Technical Services, LLC (DLE), and DLE has been a prime contractor for the Department of Energy since 2012. Rob is one of the leading experts in causal analysis, with over 30 years of experience in leading and facilitating root cause analyses, event investigations, and assessments at commercial nuclear power plants, the US Nuclear Regulatory Commission (NRC), the DOE, the US Department of Defense (DOD), and Engineering firms.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey welcomes back Chris Wubbolt to get a better understanding of the unique data integrity and validation oversight needed in virtual environments in a post-pandemic world. Stacey and Chris discuss the challenges for businesses of all sizes whether they use a hybrid or remote model.
Resources From This Episode:
FDA Provides Guidance on Remote Interactive Evaluations
COVID-19 - US Food and Drug Administration Guidelines
IVT's Annual Computer Systems Validation and Software Assurance Week Compendia
Chris Wubbolt, Principal, QACV Consulting
Chris has provided quality assurance and computer validation consulting services since 2001, specializing in validation of computerized systems, as well as quality assurance activities such as auditing, training, and quality improvement processes. Prior to becoming a consultant, Chris worked in Computer Systems Validation and Quality Assurance roles for Aventis Pasteur, Johnson & Johnson’s McNeil Consumer Products Company, and Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published a guidance document on validation of laboratory systems, as well as a chapter chair for the DIA committee developing guidance on computerized systems used in clinical research. Chris can be reached by email at Chris Wubbolt chris.wubbolt@QACVConsulting.com.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Chris Flask and they discuss how covid has impacted the drug supply chain, how the drug supply chain will look as we return to normal operations, and what the future has in store for this part of the industry.
Resources for this Episode:
-
New Bill Enacted Requiring Forecasting of Medical Device and Supply Shortages
-
FDA Drug Product Tracing Requirements – Overview
-
FDA Drug Product Tracing Requirements – The Bill
Chris Flask,
Global Business Capability Owner,
Roche Warehousing
With over 20 years in Pharma, Chris has held a variety of roles in Manufacturing, Strategic Development, and Supply Chain. All of these roles have required the development of Business Continuity Plans to ensure the continued supply of critical medicines to patients across the globe. Prior to his current role, Chris led the North America hub warehouse for Roche Drug Substance, managing the flow of $40 billion dollars worth of product annually.
Chris is currently the Global Business Capability Owner for Roche Warehousing. In this role, Chris is responsible for aligning the business processes used by over 60 warehouses worldwide. Chris holds a bachelor’s degree in Biochemistry from UCLA and a Master’s in Business Administration from UC Davis. Chris is a Black Belt in Lean/Six Sigma methodology and is Certified in Production Inventory Management by APICS.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Karen Ginsbury to chat about the guidances available for the Quality Management System, the progression of regulatory guidance and expectations, whether or not they are helping or hindering the process, and how we can move forward with risk-based critical thinking.
Karen is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey welcomes back Ivan Soto, to discuss strategies that enable the implementation of a risk-based change management process. Utilizing a risk-based lifecycle approach to manufacturing allows us to identify, analyze, understand, manage and report any risk, or potential risk throughout the lifecycle. When it comes to change control, it can be much more challenging to apply risk-based methods.
Ivan Soto is the Director CQV at Emergent BioSolutions, he is responsible for leading the commissioning, qualification, and validation activities at the Canton Massachusetts manufacturing facility. He has been in the industry for over 20 years and held several technical and management positions at different biotech and pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control, and Quality Assurance, Manufacturing, and Business Strategy. Ivan is also a contributing editor for the Journal of GxP Compliance and Journal of Validation Technology. He has a B.S. in Chemistry from the Pontifical Catholic University of Puerto Rico.
Disclaimer: The views expressed in this podcast are those of the guest alone and do not represent the views of Emergent BioSolutions.
Resources:
https://www.ivtnetwork.com/article/streamlining-change-control-implementing-risk-based-change-management-process
https://www.fda.gov/media/85281/download
https://picscheme.org/docview/3817
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance the ways in which they perceive and manage risk.
In this episode, our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussion on the ways in which bias and heuristics impact risk management, risk identification, and the decisions made during the process.
Resources from this episode:
- ICHQ9 on Quality Risk Management
- Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I—The Role of Human Heuristics
- Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part II: Risk Communication and Perception Issues
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Igor Gorsky, author of Principles of Parenteral Solution Validation, A Practical Lifecycle Approach. Stacey and Igor discuss the history of Parenteral Process Validation and why the resources in this manual are so important in this day and age.
Resources from this episode:
Principles of Parenteral Solution Validation: A Lifecycle Practical Approach written by Igor Gorsky and Harold Baseman, published by Elsevier
Process Validation: General Principles and Practices - FDA
ICH guidance Q8 Pharmaceutical Development published May 2006
Q&A for the current working procedure for implementing the Q8, Q9, and. Q10 guidance's
Slides referenced by Igor
Igor is the principal consultant at Valsouce Inc. He also is a Pharmaceutical and Biotechnology Industries’ Leader with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. Proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10, and Q11 in a variety of pharmaceutical facilities. Expertise in implementing Quality by Design in the manufacturing environment throughout commercial product launch. Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA, and other regulatory organizations.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out the website at http://ivtnetwork.com.
This week, Stacey welcomes Justin Bechtel, Lead of Business Development for PharmAllies. Stacey and Justin discuss the future of technology in finding the Secret to Individualized Medicine with one part AI and one part 3D printing. Providing a more personalized medicine and drug delivery system is beginning to be a bigger part of what we do each day. Through the use of new technologies and with risk-based systems in mind, we can more accurately tailor products to provide the best response, highest integrity, and lowest risk, and AI is only one part of that effort.
Resources from this episode: http://www.ivtnetwork.com/sites/default/files/Artificial%20Intelligence%20Paired%20with%203-D%20Printing.pdf
https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
https://www.fda.gov/medical-devices/products-and-medical-procedures/3d-printing-medical-devices
Justin Bechtel, Lead of Business Development
PharmAllies
Justin works as Lead of Business Development for a boutique consulting firm that specializes in Biopharma, Biotech, and medical device industries. His educational background includes both a degree in biology and a Doctorate in Physiotherapy with a focus in pediatrics and the spine. His passion is centered around providing a partner experience that includes both exceptional service and transparent communication. Justin works with a team that utilizes project management methods, Lean Six Sigma tools, and risk-based engineering in order to produce a product of excellence. His specialty is developing teams that deliver a successful project and program implementation to help clients streamline efficiency, increase productivity, and create risk-based compliant systems.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast
This week, Stacey is joined by Dr. Ginette Collazo, CEO of Human Error Solutions. Stacey and Ginette provide some insight into the identification and reduction of human error in GMP facilities. In pharmaceutical manufacturing, upwards of 80% of process deviations can be attributed to human error. While regulatory agencies make clear that all deviations, including those caused by human error, must be fully investigated – can we say that we are effectively doing that as an industry?
About Our Guest:
Dr. Ginette M. Collazo is CEO of Human Error Solutions. She obtained her PhD. in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. She possesses over 10 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development, and Human Reliability fields. Ginette has worked for Bristol Myers Squibb, Johnson & Johnson, Schering Plough, and Wyeth. She has completed specialized studies in Human Reliability and has authored various publications on this topic. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn't when trying to change a culture from an error-tolerant environment to an error-free learning organization. Ginette has spoken about this topic in numerous professional conferences, including American Institute for Chemical Engineers, the Center for Chemical and Process Safety, the American Society for Quality, Interphex, and FDAnews.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast
This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance the ways in which they perceive and manage risk.
This week our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussion on the ways in which bias and heuristics impact risk management, risk identification, and the decisions made during the process.
Resources from this Episode:
Understanding Problems of Subjectivity and Uncertainty in Quality Risk Management -https://www.ivtnetwork.com/article/understanding-problems-subjectivity-and-uncertainty-quality-risk-management
Risk Analysis and Ordinal Risk Rating Scales A Closer Look - https://www.ivtnetwork.com/article/risk-analysis-and-ordinal-risk-rating-scales%E2%80%94-closer-look
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast
This week, Stacey welcomes back Bernard Hsu and Paul Pluta to talk about the curious case of death by black licorice. Unanticipated illness and even death due to unexpected effects of ingredients in the foods or medicine we consume occurs all too often. Sometimes these are deliberate, with people consuming more than prescribed or mixing medications. The IVT Network recently published a blog post Unexpected Toxicity From Drug Products on this very topic. Today we will discuss this case and many more as we discover the associated science with two of the authors. Bernard Hsu and Paul Pluta.
For more information on Computer Systems Validation & Software Assurance Week Virtual Event, visit: https://informaconnect.com/it-computerized-systems-validation-csv/?utm_source=IVT%20Network&utm_medium=Podcast&utm_campaign=CBI2833V%20-%20IVT%20Network%20Podcast&utm_content=CBI2833VIVTPodcast&tracker_id=CBI2833VIVTPodcast
Resources for this episode:
Unexpected Toxicity from Drug Products: https://www.ivtnetwork.com/article/unexpected-toxicity-drug-products
A Man Ate 2 Pounds, Licorice Candy. This Is What Happened To His Organs: https://youtu.be/qg76qIZ4BQ8
A Boy Ate 150 Gummy Vitamins For Breakfast. This Is What Happened To His Bones: https://youtu.be/mZ6nREONy_4
A Boy Ate 25 Laxative Brownies In 1 Hour. This Is What Happened To His Kidneys: https://youtu.be/TMy0vJfKvzI
A Man Ate 100 Zinc Vitamin C Gummies Every Day. This Is What Happened To His Spinal Cord: https://youtu.be/oeyt2zVqCG8
A Woman Drank 1 Liter Soy Sauce Colon Cleanse In 2 Hours. This Is What Happened To Her Brain: https://youtu.be/QiBpKuTrFrw
A TikToker Drank 1 Liter Cough Syrup. This Is What Happened To His Brain: https://youtu.be/QKIobyk6Isc
A Mom Drank 3 Gallons Water In 2 Hours. This is What Happened to Her Brain: https://youtu.be/J3HivpHP-5I
A TikToker Drank 1 Bottle Nutmeg Spice. This is What Happened to His Brain: https://youtu.be/Gl3H23g5kT0
A Grandma Ate Cookie Dough For Lunch Every Week. This Is What Happened To Her Bones: https://youtu.be/Cwa8PdtWapE
Bernard Hsu, PharmD, Associate Director, Novartis Oncology. Bernard has a decade of experience in pharmaceutical product development at major pharmaceutical companies spanning all phases of development. Earlier in his career, his clinical training was in emergency medicine and toxicology. He is now Associate Director in Oncology Medical at Novartis. Most of Bernard's work today is in medical and scientific communications, both within the industry and to the general public.
Paul Pluta, Ph.D., Editor-in-Chief, IVT Journals. Paul has extensive pharmaceutical industry and university academic teaching experience, with many years managing validation in the industry. He has written chapters and edited books on cleaning validation and has published more than 100 papers and given numerous presentations. Pail has been involved with the Journal of Validation Technology and Journal of GXP Compliance as a writer and editor-in-chief for more than 10 years.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Roberta Goode to talk about patient safety and how medical packaging is a key component of that. Stacey and Roberta discuss the nuts & bolts around “Selecting medical device packaging materials and sterilization methods to achieve appropriate sterility assurance levels and sterile barrier integrity throughout the labeled shelf life.”
Resources from this episode:
ISO 14971:2019 Medical devices – Application of risk management to medical devices - https://www.iso.org/standard/72704.html
ISO 24971:2020 Medical devices – Guidance on the application of ISO 14971 - https://www.iso.org/standard/74437.html
ISO 11607:2019 Packaging for terminally sterilized medical devices - https://www.iso.org/standard/70799.html
ISO 13485:2016 Quality Management System for medical devices - https://www.iso.org/standard/59752.html
21 CFR 820 Quality System Regulation - https://www.govinfo.gov/app/details/CFR-2011-title21-vol8/CFR-2011-title21-vol8-part820
ASTM D4169 -16: Standard Practice for Performance Testing of Shipping Containers and System - https://www.astm.org/DATABASE.CART/HISTORICAL/D4169-09.htm
ISTA 2a: Partial Simulation Performance Tests - https://ista.org/test_procedures.php
Roberta Goode, Principal, Altrec
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Today Stacey Bruzzese is joined by guest Rick Rhoads to discuss lessons learned in performing stability tests.
Traditionally, compounding pharmacists have relied on professional experience and published data to determine product stability. Based on this knowledge, compounders have extended beyond use dates when deemed safe and effective. With rapidly changing guidelines, these kinds of judgement calls are no longer allowable. Many compounders are forced to conduct expensive and time consuming stability studies to extend the BUDs for compounded sterile preparations.
• Article: Lessons Learned from a Trimix Stability Study in 503A Compounding Pharmacy by Rick Rhoads, PharmD.
• USP Stakeholder Engagement Plan for Beyond Use Dates (795) (797) • USP Review Perspective on Pharmaceutical Quality
• Historical: Beyond use date (BUD) refers to the date or time after which a compounded sterile/non-sterile preparation
• May not be stored and based on the original date of compounding. BUDs help decrease the risks to patients cause by physical or chemical degradation, microbial contamination and proliferation, and impact on the integrity of the product and it’s container. Compounding Pharmacist are faced with several challenges surrounding BUDs including, varying regulations from state to state, lack of stability testing on compounded preparation, lack of prior knowledge or experience with either the components of a compound, or the compounded preparation and many instabilities cannot be detected without the use of analytic equipment.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week our series coordinators, Lori and Nuala, will engage their guest Valerie Mulholland in a lively discussion on a critical aspect of Risk Management, namely the skills and confidence necessary to making effective and timely risk-based decisions.
Articles:
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Quality Risk Management: Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making https://arrow.tudublin.ie/level3/
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Role of Senior Leadership in Quality Risk Management | IVT - Risk - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management
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Understanding the Concept of Formality In Quality Risk Management http://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management-0
Other Resources:
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ISO 31010 – Risk Management - https://www.iso.org/iso-31000-risk-management.html
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ICH Q9. Risk Based Decisions We first encounter it in the Introduction to the guideline: “Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.” And specifically, “…some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.”
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Harsha Chulki and Stephen Cook. Validation documents are critical to both the internal processes, and external communications, in regulated industries such as pharmaceutical and medical device organizations. Properly recording and managing data is necessary to ensure the integrity and reliability of records. Good Documentation Practices (GDP) lay down the guidelines for preparation, recording, and correction of data as well as the maintenance of the records throughout the lifecycle of a document.
Resources for episode:
• Compliance Group Webinar Resource: https://www.complianceg.com/webinar
• Follow Compliance Group Blogs: https://www.complianceg.com/blog
• Annex 5 - WHO | World Health Organization
• PQ Forum #10: Technical Writing for Validation
• PQ Forum #18. PV Stage 1 Technical Report Format
Harsha Chulki is the Head of Global IT, Quality & CSV at ICU Medical. He is a seasoned IT leader with over 15 years of leadership and program management experience building multiple, high performing teams across multiple industries. Chulki is also the Architect of Integrated IT Compliance model with experience installing centralized controls across IT (GxP, SOX, HIPAA, Non-GxP). He can be reached at harsha.chulki@icumed.com
Stephen Cook is the VP, QUALITY AND COMPUTER COMPLIANCE at Compliance Group Inc. He has 20+ years of experience in the field of computer systems validation and is an expert on Computer Software Assurance (CSA). He believes that a strong partnership between IT, Quality and the business can lead to creative solutions and that the really good work gets created outside the SOP. He can be reached at stephenc@complianceg.com.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Digitization Of Validation For Effective Off-Site Regulatory “Review” And “Inspection”
This week, Stacey is joined by Ajaz Hussain, Alton Johnson, and Steve Thompson. As agencies like the FDA continue to rely on virtual inspection, we need to take a look at the process, including a review of documents and processes. How can these inspections be more hands-on and eyes-on, allowing for efficient and accurate outcomes?
Resources from this episode Article - https://www.ivtnetwork.com/article/digitization-validation-effective-site-regulatory-%E2%80%9Creview%E2%80%9D-and-%E2%80%9Cinspection%E2%80%9D
Dr. Ajaz Hussain, Ph.D., Advisory Board Chairman, ValGenesis, Inc.
Dr. Hussain is globally recognized for his tireless efforts to improve the predictability of medicinal product development, manufacturing, and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science, he led some of the U.S. Food and Drug Administration's major initiatives to develop regulatory policies that already have and will continue to have, a significant impact on product development and approval in many geographies. His corporate experience includes leadership of the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein, and Complex Generic products at Sandoz. At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure the credibility of scientific evidence to seek regulatory discussions and submissions. His experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. He also has extensive teaching experience, he served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program on Computer-Aided Formulation Design. Based on his broad experience in academia, US FDA, and industry he founded his consulting practice Insight Advice & Solutions LLC.
Alton Johnson, Ph.D., Alton Johnson Consulting, LLC
Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology, and business solutions. In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation, pharmaceutical technology, business development, and compliance. He has 30-plus years of leadership experience at Pfizer across, Technical Services, Innovation, and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing, and Pharma 4.0, for organizations including ISPE, DIA, PDA, and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH-sponsored Engineering Research Center.
Steven D. Thompson
Steve has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that include biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and is a regular speaker on industry trends and best practices.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Dr. Willis Thomas to talk about reducing human error in pharmaceutical manufacturing. Efforts to investigate root causes are typically incomplete or poorly performed. Most regulatory authorities no longer accept human error as a justifiable cause of errors, making it necessary, now more than ever, to ensure proper systems are in place, employees are thoroughly trained, procedures are being followed and equipment is not deficient in any way to reduce or prevent human error.
Dr. Thomas has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations. He has been in senior management for life sciences companies for the past 15 years. Dr. Thomas, in his current full-time role, is involved in preventing and reducing human error from an HR perspective. He is also adjunct faculty at the Lake Forest Graduate School of Management, International Institute for Learning and Institute of Validation Technology. Dr. Thomas’ publications have received global recognition from associations such as the Project Management Institute (PMI) where he received the Cleland Award for “The Basics of Project Evaluation and Lessons Learned.” This book was an 8-year effort that enhanced the framework for the evaluation of projects using the PMBOK® Guide. He has been a featured speaker on an international basis and has received the Apex Publication Excellence Award for implementing useful tools for project management, evaluation and training, and has been a member of the speaking faculty for IVT since 2005 and responsible for US Human Resources for PQE Group, Inc. In addition, he holds the certified performance technologist certification (CPT) from ispi.org.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Welcome back to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
In this episode our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around risk curious concept, and expand into the why’s and why not’s and the views of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk management process, a top-down approach to building culture, and the need for critical thinking and risk-based decision making.
Links to Risk Revolution Takeaways:
- The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693
- Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management
- Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge
- Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report
- PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160
- PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148
Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.
Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.
Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics.
Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Chris Wubbolt to help us better understand how to establish criteria around “critical data” and managing it within the data integrity programs of our own business.
What is critical data, and why is it important to define it?
What are the first steps in establishing the criteria desired to identify critical data?
Once we definite critical data, how fully integrate it into our data integrity program?
How does “critical” data impact validation?
What are some key considerations in critical data collection, and what are the biggest mistakes made here?
Given that critical and non-critical data can be stored and maintained in the same database, what special protections of records controls do we need to be mindful of?
What are the biggest challenges around critical data, and record controls?
Can you highlight a couple of examples where data collection or storage failures have happened?
Thinking about critical data reviews in your SOPs, review frequency and risk assessments. What are regulators expectations around critical data during an audit trail review?
What are the most common failures or findings during these reviews?
Chris has provided quality assurance and computer validation consulting services since 2001, specializing in validation of computerized systems, as well as quality assurance activities such as auditing, training and quality improvement processes. Prior to becoming a consultant, Chris worked in Computer Systems Validation and Quality Assurance roles for Aventis Pasteur, Johnson & Johnson’s McNeil Consumer Products Company, and Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published a guidance document on validation of laboratory systems, as well as a chapter chair for the DIA committee developing guidance on computerized systems used in clinical research. Chris can be reached by email at Chris Wubbolt chris.wubbolt@QACVConsulting.com.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined once again by Rich Forsyth. Stacey and Rich discuss some strategies for simplifying the cleaning validation activities and achieving efficiencies throughout the process.
Richard Forsyth, Principal Consultant Forsyth Pharmaceutical Consulting Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
Links:
FDA Cleaning Validation Guideline from CFR 211.67 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67
FDA CFR 211 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
FDA Questions & Answers on Current Good Manufacturing Practices—Equipment - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment
EMA Cleaning Guidance - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
EMA Cleaning Validation Guideline on setting HBELs - https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
QnA on the implementation of the above guideline
EMA - https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf
ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle-applications-methods-controls
WHO Cleaning Guidance - https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_in_cleaning_validation.pdf?ua=1
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Bernard Hsu and Paul Pluta. Stacey and her guests talk about, Food safety and contamination is a concern in the manufacturing plant and in the home. Contamination in the plant due to substandard food handling may ultimately contaminate manufactured product and may sicken employees. Food safety must not be taken lightly; US CDC estimates foodborne illnesses annually sicken 48 million people, hospitalize 128,000 people, and kill 3,000 people – testament to general lack of knowledge or carelessness regarding safe food practices.
Bernard Hsu, PharmD , Associate Director, Novartis Oncology Bernard has a decade of experience in pharmaceutical product development at major pharmaceutical companies spanning all phases of development. Earlier in his career, his clinical training was in emergency medicine and toxicology. He is now Associate Director in Oncology Medical at Novartis. Most of Bernard's work today is in medical and scientific communications, both within the industry, and to the general public.
Paul Pluta, Ph.D., Editor-in-Chief, IVT Journals Paul has extensive pharmaceutical industry and university academic teaching experience, with many years managing validation in industry. He has written chapters and edited books on cleaning validation. More than 100 publications and presentations all told. Pail has been involved with the Journal of Validation Technology and Journal of GXP Compliance as a writer and editor-in-chief for more than 10 years.
Resources from this episode Peer-Reviewed Articles:
• Compliance Case Study #16: Microbial Contamination From Foods
• CQV #9: What, How, and Why of Handwashing Bernard’s Videos:
• A Student Ate 5 Day Old Pasta For Lunch. This Is How His Liver Shut Down.
• A Mom Ate 5 Day Old Sushi 🍣 For Dinner. This Is What Happened To Her Brain.
• A Toddler Played With His Cat. This Is What Happened To His Brain.
• A Student Ate Leftover Potato Salad For Lunch. This Is What Happened To Her Liver.
• A Grandma Ate Cookie Dough For Lunch Every Week. This Is What Happened To Her Bones.
• A Man Was Licked By His Dog. This Is How His Organs Shut Down.
• A Student Ate Gas Station Sushi For Breakfast. This Is What Happened To His Stomach.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined once again by Alan Golden. On this episode Stacey and Alan talk about ways in which medical device companies can prepare for audits, know what to expect during the audit, and how they should respond to audit findings.
Alan Golden, MS, Principal Design Quality Consultants, LLC Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years’ experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018.
Links: CFR 21 - Part 806.10. - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.10 CFR 21 – Part 806.20 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.20 ISO 13485:2016 - Medical device - QMS- Requirements for regulatory purposes - https://www.iso.org/standard/59752.html
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Welcome to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk.
On this episode our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, covering some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from here time as an agent at MHRA.
Links to Risk Revolution Takeaways:
- The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693
- Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management
- Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledge
- Link to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report
- PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160
- PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148
Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.
Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.
Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics.
Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined once again by Dr. Tim Sandle. On this episode Stacey will speak with Dr. Tim Sandle about the potential risks to cleanrooms and laboratories posed by some of today’s fads.
Links:
Microbial Contamination Concerns Linked With E-Cigarettes And Vaping Products: https://www.ivtnetwork.com/article/microbial-contamination-concerns-linked-e-cigarettes-and-vaping-products
Alternative Risks To Cleanrooms Presented By People: Tattoos, Piercings, Sunbeds: http://www.ivtnetwork.com/article/alternative-risks-cleanrooms-presented-people-tattoos-piercings-sunbeds
FDA (2019) Think Before You Ink: Are Tattoos Safe?: https://www.fda.gov/consumers/consumer-updates/think-you-ink-are-tattoos-safe
Dr. Tim Sandle Ph.D., is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. Dr. Sandle currently works for an international sterile products manufacturer and he is additionally a visiting tutor with the University of Manchester (lecturing in pharmaceutical microbiology), a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig), and a supporter of several other societies relating to pharmaceuticals and healthcare, including IVT. Dr. Sandle also serves on a number of advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, over 125 peer reviewed papers and some 400 technical articles. Dr. Sandle is a regular presenter at conferences and webinars, having delivered over 150 presentations.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Emma Ramnarine to continue their series discussing One-Voice-of-Quality. This discussion focuses in on the details for a greater understanding around the how’s and who’s that are necessary to this One-Voice-of-Quality vision.
Emma has over 15 years of experience in the pharmaceutical, biotechnology and medical device industry in the area of Quality System with focus on developing and leading Quality Risk Management (QRM), validation, and change control. She is a worldwide-recognized expert on QRM, providing QRM leadership, governance, guidance, and training to regulatory authorities and at industry forums. Emma has been an active member of the Parenteral Drug Association (PDA) for 13 years. She most recently led PDA”s Task Force for Technical Report No. 68 on “Risk Based Approach for Prevention and Management of Drug Shortages” and is also a member for PDA on the inter-association European Drug Shortages Team that was formed under EMA”s direction. She also led the Task Forces for PCMOSM Technical Report Series No. 54 on “Implementation of Quality Risk Management”. Emma joined the PDA Board of Directors as of Jan 2015, has been on PDA”s Regulatory Affairs and Quality Advisory Board (RAQAB) since 2013, and also co-leads PDA”s QRM Interest Group. Emma holds an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India.
Read more from Emma on this topic:
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Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
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Industry One-Voice-of Quality Concept Paper: Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transforms Post-Approval Change Management
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Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?
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Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.
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PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry
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PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages
Website link to discussion topic: https://prst.ie/1vq
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey presents the Validation Week awards ceremony. You'll find who won this years awards and what those recipients did to achieve their awards.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Rich Forsyth, Forsyth Pharmaceutical Consulting. Stacey and Rich discuss the lifecycle approach to cleaning validation, and the importance of creating cGMP approved cleaning programs that encompass the applications, methods and controls necessary for creation and launch of compliant cleaning programs that meet or exceed regulatory expectations.
Rich is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades. He has been involved with Cleaning Validation for over 20 years. Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.
Links:
FDA Cleaning Validation Guideline from CFR 211.67 -
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67
FDA CFR 211 -
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfmCFRPart=211
FDA Questions & Answers on Current Good Manufacturing Practices—Equipment - https://www.fda.gov/drugs/guidances-drugs/questions-and-answers-current-good-manufacturing-practices-equipment
EMA Cleaning Guidance -
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
EMA Cleaning Validation Guideline on setting HBELs -
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf
QnA on the implementation of the above guideline EMA - https://www.ema.europa.eu/en/documents/other/questions- answers-implementation-risk-based-prevention-cross-contamination-production-guideline_en.pdf
ISPE Cleaning Validation Guide - https://ispe.org/publications/guidance-documents/guide-cleaning-validation-lifecycle- applications-methods-controls
WHO Cleaning Guidance - https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_Rev.1_points_to_consider_hbels_ in_cleaning_validation.pdf?ua=1
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Eric Kastango and Kevin Hansen to talk about compounding and specialty pharmacy, regulations, innovations and reputations. Compounding Pharmacists have a very challenging, and rewarding job, in their development of specialized medicines for individualized patient care. For many, there is satisfaction in working to solve the needs of patients through innovative partnership with the patient and their practitioner. Too often professionals in this space are mired by regulatory inconsistencies, special interest groups, lack of transparency and a tarnished reputation, all of which make this highly challenging job even more difficult. Today we will talk about some of the hurdles and opportunities in Compounding.
Eric Kastango, Expert Consultant and Pharmacist Eric has dedicated his life's work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. He has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for Coram Healthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019.
Kevin Hansen, PharmD, Assistant Director of Pharmacy Moses H. Cone Memorial Hospital Dr. Kevin Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’s Sterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM).
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On this edition of the QRM Series Stacey, Lori, and Nuala are joined by Chris Flask. The team are going to take a look at risk management in the broader context and get some facts straight!
De-risking your supply chain: http://www.ivtnetwork.com/sites/default/files/NUALA-IVT%20Network%20-%20De-risking%20Your%20Supply%20Chain.pdf
Risk Assessment Steps for Success: http://www.ivtnetwork.com/sites/default/files/NUALA-Risk Assessment Steps for Success_PRST@TUDublin and BioPharmChem Ireland.pdf
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Dr. Ross Caputo, President Eagle Analytical. Stacey and Dr. Caputo discuss contamination control. Contamination control is very important for medical devices, pharmaceuticals, preparations, tissue materials and other materials that claim to be sterile or free from viable microorganisms. Any contamination that does occur must be thoroughly investigated, which often is time consuming, causing potential delays in production, and this is true for compounding pharmacies of all types.
Dr. Caputo has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing focusing on process optimization and control. He has authored more than 50 publications and owns 15 patents, all related to infection control, sterilization processes and the production of sterile product. Throughout his career, Dr. Caputo has been an active participant and committee member of organizations such as AAMI/ISO and PDA, which are charged with the development of standards for the regulated marketplace. He has a PhD in Microbiological Physiology and Immunology from Miami University.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Dr. Kevin Hansen, PharmD Assistant Director of Pharmacy. Stacey and Dr. Hansen discuss how innovations in the RTA space are changing the way some hospital systems and their compounding pharmacies source these forms of drugs.
Dr. Hansen is Assistant Director of Pharmacy at Moses H. Cone Memorial Hospital in Greensboro, North Carolina and provides leadership and operational oversite for pharmaceutical compounding and pharmacy perioperative services. He is a preceptor for the Health-System Pharmacy Administration residency program. In addition, Dr. Hansen serves as adjunct faculty for The University of North Carolina Eshelman School of Pharmacy. Within the Moses H. Cone Memorial Hospital, as part of the Cone Health system, Dr. Hansen is involved in several committees and initiatives related to his practice interests of pharmaceutical compounding, handling hazardous drugs, medication and compounding safety, drug shortage management, and pharmacy perioperative services. He is a member of ASHP and the North Carolina Association of Pharmacists (NCAP). He currently serves a leading role through ASHP’s Sterile Products Workgroup, as part of the Section of Pharmacy Practice Managers (SPPM).
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On this episode, Stacey is joined by Emma Ramnarine, Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. Stacey and Emma discuss managing high volume of PACs in a short timeframe and how to solve this problem.
Emma is Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. This initiative is sponsored by Chief Quality Officers of 20+ global pharma companies who have decided to speak with a unified voice, and develop standard solutions to reduce global PAC complexity. Emma has 20+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Risk Management, Quality Control and Quality Management Systems. She is currently on the PDA Board of Directors and has led several PDA Task Forces and Technical Reports (TR) including a series of TRs on “Implementation of Quality Risk Management” and “Risk Based Approach for Prevention and Management of Drug Shortages”. Emma is currently Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio. Prior to this, she was the Global Head of Analytical Science and Technology at Genentech/Roche, providing strategic direction and leadership for product control systems lifecycle management, analytical technology innovation and tech transfers. She is also a worldwide-recognized expert on Quality Risk Management (QRM), and continues to provide QRM training to regulatory authorities and at industry forums. Emma holds an M.S. in Pharmaceutical Sciences from the University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India. She is currently pursuing her PhD in Pharmaceutical Sciences from Technological University Dublin; her research focuses on this topic of transforming PAC management to solve the continual improvement and innovation challenge in the pharmaceutical industry.
Read more from Emma on this topic:
Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches
Industry One-Voice-of Quality Concept Paper: Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transforms Post-Approval Change Management
Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?
Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction
PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry
PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Raymond McKinney, Director NNIT. Stacey and Raymond talk about the perceptions and realities around cloud technology implementation for the life sciences industry.
Raymond McKinney Ray is a leading consulting, implementation and operations subject matter expert for IT operations in the pharmaceutical industry. He is responsible for delivery management and business development for IT services with an expertise in taking unstructured problems, performing process analyses, and constructing KPI-driven solutions to ensure measurement of achievement.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Lori Richter and Nuala Calnan to talk about risk management and quality management. This is the first episode in the QRM Corner series. We will cover some of the basics of Quality Risk Management in today’s episode and subsequently move on to “deep dives” focused on some of the more intricate and nuanced areas of Risk Management in future episodes.
• ICH Q9 Quality Risk Management Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management
• Annex 1 Manufacture of Sterile Medicinal Products: https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf
• WHO Risk Management Guidance: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf?ua=1
• European Medicines Agency Risk Management Guidance Format: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf
• European Medicines Agency Risk Management Plans: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans
Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.
Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Marty Lipa, Executive Director Knowledge Management, Merck & Co. Stacey and Marty discuss the importance of “managing knowledge as an asset” in the pharmaceutical industry and learn how every company can begin to capitalize on this very important product.
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Link to ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
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Link to find out more about the Knowledge Transfer Enhancement Framework (Chapter 6): https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1011&context=ditpress
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Effective Knowledge Transfer During Biopharmaceutical Technology Transfer: https://www.ivtnetwork.com/article/effective-knowledge-transfer-during-biopharmaceutical-technology-transfer
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Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers: https://www.ivtnetwork.com/article/managing-knowledge-and-risk-%E2%80%93-literature-review-interdependency-qrm-and-km-ich-q10-enablers
Marty has over 25 years’ industry experience and 12 years’ experience in Knowledge Management. He has published several industry specific works and is currently pursuing his Ph.D. at Technological University Dublin in Pharmaceutical and Regulatory Science with an emphasis on Knowledge Management. Lipa also leads the Knowledge Management Center of Excellence for the Manufacturing Division of Merck & Co., Inc.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Igor Gorsky, Senior Consultant Val Source Inc. Stacey and Igor discuss current restrictions and guidelines for cleaning, the shift to more science risk-based approach, streamlining the cleaning process while assuring patient safety and product quality.
Igor is an industry leader in Pharmaceutical and Biotechnology with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. He has a proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10 and Q11 in variety of pharmaceutical facilities. Igor brings expertise in implementing Quality by Design in manufacturing environment throughout commercial product launch; Proven track record in building Validation organizations establishing and implementing validation policies and training programs; Direct personal interface with FDA, MHRA, ANVISA and other regulatory organizations.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey hosts a panel discussion on computer software assurance. Stacey is joined by industry experts, Raechelle Raimondo, Ken Shitamoto, Pritam Khade, and Senthil Gurumoorthi, to talk about the upcoming guidelines from the FDA on computer software assurance, testing requirements, IT automation, risk, quality culture, and critical thinking mindset in the industry.
Raechelle Raimondo - Raechelle has more than 20 years of experience working for large/global corporations, small businesses and start-up companies. A proven history of implementing global systems utilizing a risk based systems lifecycle (SLC) approach and managing teams to support multiple projects, including forecasting and managing budgets. Strengths include leadership, portfolio/program management, delivering results, managing multiple priorities, effecting change, building teams, problem-solving, using interpersonal skills to build effective relationships, and understanding the link between technology & business needs to deliver compliant solutions that optimize processes & efficiencies.
Ken Shitamoto - Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.
Pritam Khade - Pritam is a Director of Global Quality Compliance at Allergan Inc.
Senthil Gurumoorthi – Senthil is a Director of IT Services at Gilead Sciences.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Felicia Ford-Rice, Senior Director Parexel International, the latest guidance from WHO about data integrity.
WHO Guideline: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_819_rev1_guideline_on_data_integrity.pdf?ua=1
Previous WHO Guideline: https://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf?ua=1
Felicia Ford-Rice leads a team of former FDA Reviewers and Investigators, and utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: Strategic GxP Compliance/ Inspection Readiness / Training / Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control / Corrective Action and Preventive Action /Product Complaint Assessments / Regulatory Action Remediation. She holds a Regulatory Affairs Certification, achieved a Master of Management in Business and a certificate in Project Management from Penn State University as well as a BS in Biology from Virginia Tech.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Steve Thompson, Director Industry Solutions, to talk about how digital technology is changing the life science industry. Stacey and Steve discuss paperless systems, remote validation, and eLogs.
Steve has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Valarie King-Bailey, John E Lincoln, and Dr. Siegfried Schmitt for a panel discussion on Life Science Industry Challenges, Opportunities, and Next Steps.
Valarie King-Bailey – Valarie is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products and solutions. OnShore’s product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market. ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works. At QUMAS, an Irish-based software company, she served as Chief Marketing Officer where she was responsible for all global tactical and strategic marketing initiatives in addition to the development of their validation toolkit. Valarie founded OnShore Technology Group in 2004. OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008). She also received a nomination for Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from the University of Wisconsin – Madison (1982).
John E. Lincoln – John is principal consultant, J. E. Lincoln and Associates LLC, assists companies in the design and implementation of complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems, fully CGMP- compliant, and which have passed FDA audits. He compiles 510(k) submissions, new and changed, product Risk Management Files / Reports per ISO 14971, Design History Files, Technical Files, and Design Dossiers. He assists companies in remediation / FDA responses, SOP writing, audits, validations, including software. His work is described in peer-reviewed technical articles and workshops, worldwide. John has also managed pilot production, regulatory affairs, product development / design control projects. He has over 35 years of experience, 21 as a full time consultant, primarily with medical devices – working with start-ups to Fortune 100 companies. He is a graduate of UCLA.
Dr. Siegfried Schmitt - Siegfried is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. Siegfried received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry. Dr. Schmitt is an active member of various industry associations, including DIA, PDA and ISPE, conference presenter and organizer of international events. He is also an accomplished author and editor, having won the coveted ‘distinguished PDA author / editor award’ in 2008 and 2012. Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Bernard Hsu, Associate Director – Novartis Oncology. Stacey and Bernard discuss the process of communicating scientific data, including benefits, risks and outcomes, of prescription drugs is not only highly regulated, it can leave the audience confused and mis-informed if not done thoughtfully and with great care.
Bernard has a decade of experience in pharmaceutical product development at major pharmaceutical companies spanning all phases of development. Earlier in his career, his clinical training was in emergency medicine and toxicology. He is now Associate Director in Oncology Medical at Novartis. Most of Bernard's work today is in medical and scientific communications, both within the industry, and to the general public.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey and Cliff speak about new ways of thinking across the industry that aim to ensure appropriate, risk-based, least burdensome validation, with a focus of validation activities, instead of the traditional “are we compliant” mentality.
For more information on this topic:
ICH Q10 Feedforward, https://www.fda.gov/media/71553/download
- Process Validation Systems Based Inspection, https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
- Operation Warp Speed, https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html
- Continuity Bill of Materials MBOM, https://www.cbsi-corp.com/wp-content/uploads/2012/02/NA50_03_Bill_of_Materials2.pdf
Cliff is a highly experienced consultant with a proven track record in efficient, agile and flexible compliance. His strengths include validation strategy, process mapping and gap analysis projects, both short and long term. He is exceptionally well regarded, and has worked collaboratively and co-authored with regulatory agencies, such as the FDA and HPRA, providing leadership training and advisory services. In addition to FDA, projects and workshops have been successfully completed for the following companies: Aveo, Amgen, Bayer, BioMarin, Celgene, Janssen, Kite, Lonza, Novartis, Parexel, Pfizer, Prolong. Cliff is also a long time contributor to the IVT Network, publishing articles in the Journal of Validation
Technology since 2010. Cliff was awarded the Kenneth G. Chapman Award in 2017 in recognition for his long standing efforts and contributions to validation.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Stacey is joined by Lori Richter and James Vesper. They talk about Adult Learning Theory and its impact on corporate training.
Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a PhD at Technological University Dublin.
Lori Richter’s Articles On The Topic:
Understanding Adult Learning Principles, CGMP Training Modalities ...
Applying Adult Learning Principles In CGMP Training
Building Effective CGMP Training Designed For The Adult Learner
James Vesper has worked in the pharmaceutical industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has authored numerous books, book chapters, articles, and also speaks and teaches at international conferences and workshops, as well as consults for the World Health Organization (WHO). He received his PH.D. in education from Murdoch University, Perth, Australia.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Holly Baldwin, Quality Validation CSV, Sanofi Pasteur. Stacey and Holly discuss the most important questions when talking about security and data integrity when dealing with third-party suppliers.
Top 10 Questions:
- Can I perform a vendor audit virtually or in-person?
- What kind of intrusion detection system does SaaS vendor use?
- Where is the primary and secondary (disaster recovery) data centers? Are either in a co-location site?
- Where and when is Quality personnel in the validation process? Pre-approval, post-approval, change management?
- How often does the SaaS vendor audit their offshore resources or third-party companies? What are the consequences if offshore company fails an audit?
- Does SaaS vendor have documentation on their APIs (Application Programming Interface) , including any existing application assessment results and reports that demonstrate security best practices and audit results?
- If your company, as Data Controller, needs to notify supervisory authority in 72 hours; what is the timeframe in which SaaS vendor will notify your company?
- How will you be notified and how long before the implementation of the releases, upgrades and patches is the notification?
- What is the SaaS vendor’s definition of an emergency change and when is Quality involved?
- For an unplanned system outage, when will you be notified? How will you be notified? When will you have access to SaaS vendor’s Postmortem and/or CAPA created for unplanned outage?
Holly Baldwin has more than two decades in the Life Science Industry, primarily as a Computer System Validation/Quality authority and resource. She is also an expert in 21 CFR Part 11 Assessments, System Development Lifecycle documentation, audit preparedness and System Validation. Holly has been a speaker and trainer, sharing her expertise globally through organizations such as IVT, ISPE, American Society of Quality, China Medical Device association and for the China FDA now called the National Medical Products Administration.
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More detailed presentation at IVT’s 26th Annual Validation Week October 28-30, 2020 in San Diego
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2017 Q&A addendum to 21 CFR Part 11 (Clinical Investigations): https://www.fda.gov/files/drugs/published/Use-of-Electronic-Records-and-Electronic-Signatures-in-Clinical-Investigations-Under-21-CFR-Part-11-%E2%80%93.pdf
- MHRA Rules and Guidance for Pharmaceutical Manufactures and Distributors, EU Guidance on GMP, Section 2, Part 1, subsection 7: Outsourced Activities
- EU GMP Annex 11, Section 3: Suppliers and Service Providers: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf
- FDA Data Integrity and Compliance With Drug cGMP, Dec 2018; http://www.gmp-compliance.org/guidemgr/files/UCM495891.PDF
- WHO TRS 996, Annex 5; http://www.gmp-compliance.org/guidemgr/files/WHO_TRS_996_ANNEX05.PDF
- FDA 21 CFR Part 820.50: “Each manufacturer shall evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements”
GDPR: https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/ and https://gdpr.eu/data-privacy/
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey is joined by Raechelle Raimondo, Executive Director Global IT Systems Assurance and Compliace at Abbvie.
Raechelle has more than 20 years of experience working for large/global corporations, small businesses and start-up companies. A proven history of implementing global systems utilizing a risk based systems lifecycle (SLC) approach and managing teams to support multiple projects, including forecasting and managing budgets. Strengths include leadership, portfolio/program management, delivering results, managing multiple priorities, effecting change, building teams, problem-solving, using interpersonal skills to build effective relationships, and understanding the link between technology & business needs to deliver compliant solutions that optimize processes & efficiencies.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
In this episode, Jim and Stacey speak about the reasoning for such an emphasis on investigations and corrective actions, highlight the current guidance on CAPA investigations, cover the best tools for investigations beyond the “5 Whys” and Fishbone diagram, dispelling the “rule of three” that many companies count on, while defining what constitutes an acceptable root cause, “human error,” “training” and “revise the procedure" over used in corrective actions, and much more.
James Vesper has worked in the pharmaceutical industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has authored numerous books, book chapters, articles, and also speaks and teaches at international conferences and workshops, as well as consults for the World Health Organization (WHO). He received his PH.D. in education from Murdoch University, Perth, Australia.
For step by step investigation advise, and tips on drilling down into the root cause for CAPA planning and analysis our listeners can revie Jim’s latest book: Root Cause Investigations for CAPA: Clear and Simple by visiting the PDA Bookstore at https://www.pda.org/bookstore/product-detail/5724-capa
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes back Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about combination products and what you need to be aware of.
- A review of the types of combo products, single-entity, co-packaged, and cross-labeled, as well as the FDA Guidance.
- The FDA’s 9 classifications for combo products – download the table
- Navigating a multi-approval process and successful development processes and timing
- Aligning the clinical trial and design validation phases in order to be efficient.
- Quality requirements under GMP and 21 CFR Part 4 including design controls for combination products to ensure that the product fulfils the requirements which were defined at the beginning of the project so that the final product fulfils the purpose.
- Design controls, a design and development plan, development activities and defining responsibility for implementation.
- Mitigating risk throughout the lifecycle of the product
- Process for reporting adverse events for combination products
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Voices in Validation, Stacey Bruzzese, IVT Network, pharmaceutical, biotech, laboratories, medical devices, patient safety, quality control, United Podcast Network, Studio 21 Podcast Café, Alan Golden, Design Quality Consultants, change control, combination products,
Stacey Bruzzese welcomes Eric Kastango to the show. Today, Stacey and Eric discuss the how FDA has implemented temporary guidelines and how companies can mitigate their risks to consumers and compounding sites.
Eric has dedicated his life’s work to patient safety through better sterile compounding, aseptic manufacturing, lean production, and robust quality management practices. has practiced pharmacy in hospital, community, and homecare settings in a variety of roles. He was previously Corporate Vice President of Pharmacy Services for Coram Healthcare and also managed a cGMP outsource manufacturing operation for Baxter Healthcare. In addition to his consulting role, Eric continues to serve as a sterile compounding, 503B outsourcing, and patient safety subject matter expert for his clients, the American Society of Health-System Pharmacists, State Boards of Pharmacy, and was one of the key US Department of Justice expert witnesses during the New England Compounding Center trials from 2017-2019.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes David Nettleton to the show. Today, Stacey and David will discuss the 6 most common problems in FDA validation and verification.
David is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications. He has completed more than 290 mission critical laboratory, clinical, and manufacturing software implementation projects, and has written 5 books on CSV subject matter.
Topics Discussed:
An explanation of what CSV entails and why it’s so important in highly regulated industries…
Understanding 21 CFR Part 11 regulation and guidance, and the confusion it often creates for many companies…
6 Common Problems:
1 - required systems
2 - software requirements
3 - other resources that can be insufficient or inappropriate
4 - vendor responsibilities
5 - Traceability is a HUGE factor in terms of FDA expectations during audits
6 – the lack of appropriate SOPs
David Nettleton, and co-author Janet Clough, recently released a new technical book Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. With the purchase of this useful guide you will also receive access to templates the authors have used as training tools for more than 1,000 companies and components of more than 300 validation projects. David is also the author of the following books which can be purchased through the PDA bookstore, or by clicking the links below:
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Risk-Based Software Validation-Ten Easy Steps (Out of Stock)
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Managing the Documentation Maze
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Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
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Commercial Off the Shelf Software Validation for 21 CFR Part 11 Compliance (Out of Stock)
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Brian Nunnally, Global Head of Quality Control – A CSL Company, to the show. Today, Stacey and Brian discuss how pharmaceutical manufacturers deal with unexpected variabilities over the lifecycle of their product.
- What is the current guidance?
- What are some of the current Control Variation tools and tactics you have seen in the pharmaceutical industry?
- Are these tools applicable to other industries, say medical devices, as well?
- Is there a significant change in the process controls being used, or the way data is analyzed?
- How do quality controls impact each area of med device processes?
- What are the most common drawbacks?
- How can pharma or device companies discover which innovative tools and technologies can have the greatest immediate impact on their business?
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Garlan Adams to the show to discuss how risk, compliance, and corporate culture matter.
- What is a culture of compliance?
- How does human error play into compliance?
- What are the biggest factors of non-compliance?
- How ethical fading has impacted corporations
- How can companies train their employees in compliance?
- How do companies adhere to compliance protocol?
Garlan Adams is an Executive Advisor/Consultant specializing in Legal, Regulatory, Risk, Compliance, and Corporate Culture matters.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Ferdi Steinmann & Jennifer Wemstrom from OpenText to the show to discuss Enterprise Information Management and how companies are adapting to a new digital age.
Visit: www.opentext.com
- How can EIM help companies achieve supply chain flexibility?
- How will EIM solutions help companies adapt to updates to technology?
- Why are EIM solutions the next step in becoming a smart organization?
- For companies yet to embrace big data platforms are their benefits in these types of sophisticated software solutions?
- What steps are being made within the industry to move to a fully digital storage system?
- What are the pros and cons of breaking free of paper documents?
Ferdi has nearly 25 years driving strategy & commercialization efforts in Biotech, Pharma, and Enterprise Software with Fortune 500 Co’s such as Merck & Co, Eli Lilly & Biogen. Ferdi’s focus is in Life Sciences (LS) strategic planning and industry marketing efforts for enterprise software solutions at OpenText today. He is energized by strategies that deliver on their promises!
Jennifer Wemstrom spearheads the Life Sciences Business Unit group within OpenText. Mrs. Wemstrom’s chief responsibility is to develop enterprise content solutions for OpenText, specializing in the areas of Clinical, Regulatory and Quality systems, utilizing OpenText’s technology, including Documentum, Documentum D2, Captiva, and InfoArchive. Jennifer joined EMC in September of 2013 and EMC was acquired by OpenText in January 2017. Prior to EMC, Jennifer was the head of Product Strategy at CSC and played a key role in the sales and development of CSC’s Documentum-based ECM product, FirstDoc®. With twenty five years of experience as a solution specialist and consultant in OpenText and other computer systems specifically related to the life science industry, Jennifer is an expert in systems supporting the management of regulatory, clinical, and quality documentation, creation of regulatory submissions, electronic document publishing as well as system validation. She has worked on dozens of content management implementation projects facilitating requirements workshops and training sessions within the pharmaceutical industry. Her role at CSC also included leading the Life Sciences Presales Group, and she has performed and managed all aspects of the presales process such as vendor analysis, RFP response, product demonstrations and requirements mapping.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes back Alton Johnson to the show to discuss companies adopting appropriate technologies and the Internet of Things.
Reference Documents:
- Internet of Things Reference Materials - https://www.dropbox.com/s/f69vtmztael36ej/Podcast%20Visual%20References.pdf?dl=0
- Guidance – Approval of GXP Documents when Working from Home - https://www.dropbox.com/s/t7t6b532ak6uu4j/Approval%20of%20GxP%20documents%20when%20working%20from%20home%20during%20the%20coronavirus%20%28COVID-19%29%20outbreak.pdf?dl=0
- Case Study #1 – https://www.dropbox.com/s/i2yddrlfh2vjy6f/Valgenesis_case%20study_Top%20Tier%20Global%20Pharma_FINAL.pdf?dl=0
- Case Study #2 - https://www.dropbox.com/s/10alrxmbmpzjpoc/Valgenesis_case%20study_ScinoPharm_FINAL.pdf?dl=0
- Case Study #3 - https://www.dropbox.com/s/z22uc4ouo00b3zs/Noven_Case%20Study.pdf?dl=0
- Case Study #4 - https://www.dropbox.com/s/0av8m16z6u3rvzu/Valgenesis_case%20study_Varian%20Medicals_FINAL.pdf?dl=0
Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology and business solutions. In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation, pharmaceutical technology, business development and compliance. He has 30-plus years leadership experience at Pfizer across R&D, Technical Services, Innovation and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing and Pharma 4.0, for organizations including ISPE, DIA, PDA and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH sponsored Engineering Research Center.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Alton Johnson to the show to discuss companies adopting appropriate technologies and the Internet of Things.
- Understanding and developing an interconnected enterprise system
- What barriers remain for companies that prohibit appropriate implementation?
- How are businesses having success with “smart manufacturing”?
- What is the impact for businesses who are just starting to implement IoT?
- What lessons have some of these companies learned during the covid-19 health crisis?
- How can businesses begin to implement IoT? Is there a roadmap?
Alton Johnson is an industry leader and expert in pharmaceutical development, manufacturing, technology and business solutions. In his current consulting role, he develops strategies and solutions for clients in the areas of new product development, manufacturing, digital transformation, pharmaceutical technology, business development and compliance. He has 30-plus years leadership experience at Pfizer across R&D, Technical Services, Innovation and Advanced Manufacturing Technology / Pharma 4.0. His extensive publications and presentations encompass Quality by Design, Risk Management, Knowledge Management, Validation, Process Analytical Technology, Continuous Processing and Pharma 4.0, for organizations including ISPE, DIA, PDA and AAPS. He has served in leadership roles for PhRMA, on the board of Smart Manufacturing Leadership Coalition, and as Chair of the Steering Committee for NIH sponsored Engineering Research Center.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing risk mitigation in SaaS Solutions.
- How SaaS works in GxP environments
- Can you use vendor supplied software for validation?
- Can we continue validation with ever changing software?
- Need to know, Compliant SaaS Provider Responsibilities
- Can cloud-based systems provide greater agility for companies?
- Risk factors still present in SaaS
- How to vet SaaS providers
Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, and John Patterson, Senior Consultant QACV Consulting, to the show. Today, Stacey, John and Chris will be discussing how to run a successful virtual audit during the Covid-19 pandemic.
- How to factor in audits into a changing schedule during a pandemic
- What goes into the decision to do a remote audit instead of on-site?
- What are the regulatory guidelines for virtual audits?
- What factors need to be considered when you do remote audits vs on-site?
- What needs to be performed before handling a remote audit?
- How can you overcome the limitations of a remote audit?
- How will the Covid-19 pandemic change the processes of audits moving forward?
- How can you have the best virtual audit experience?
John is a technology savvy leader, focused on improving human health through the compliant and secure enablement of new business technologies, particularly GxP, IT/digital systems. John is experienced in IT GxP Inspection readiness and Quality Management Systems (QMS) development, Cyber Security and Data Protection, Vendor Audit Planning, Preparation, Execution & Response, Standards Interpretation, Development & Governance, Data Privacy Enablement and Compliance, Strategy Development, Organizational Design & Governance, Records Management & E-Discovery Compliance, and Emerging IT/Digital Tech (e.g. Cloud, Mobile) Regulatory Surveillance & Advocacy.
Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment.
- Current guidelines that apply to Data Integrity
- What are the most important data integrity issues?
- The need for original documents for investigations
- What should SOP’s entail for firms to manage data risks?
- Specific regulations for eRecords and eSignatures
- Use of electronic documents for data integrity
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What have companies gone through during an audit of this type?
-
Investigations Operations Manual 2020 - https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM607759.pdf
- Guide to Inspections of Pharmaceutical Quality Control Laboratories - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/pharmaceutical-quality-control-labs-793
- Guidances and Manuals on Pharmaceutical Quality - https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality
- MHRA Guidance - Good clinical practice for clinical trials - https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials
- MHRA Inspection Toolkit - http://www.ct-toolkit.ac.uk/routemap/mhra-inspection/
- MHRA Inspectorate Computer System Validation – GCP - https://mhrainspectorate.blog.gov.uk/2017/04/20/computer-system-validation-gcp/
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1
Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes back Ivan Soto, Director Manufacturing Validation Emergent BioSolutions. Stacey and Ivan talk about the current challenges with the implementation of quality metrics for validation.
Stacey and Ivan discuss:
- What current challenges are companies facing when implementing new metrics?
- Which metrics have proved to be the most useful?
- FDA Guidance on Submission of Quality Metrics Data
- How quality metrics help us understand the lifecycle of equipment
- What do companies need to know when implementing metrics programs for validation?
- How can we account for supply chain elements?
- How will our current systems adapt to handle technological changes?
- What role will the FDA continue to play in oversight?
Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Dr. Siegfried Schmitt back to the show. Today, Stacey and Siegfried discuss how the supply chains have been interrupted and what we can do to solve these issues.
- Supply Chain has been disrupted by covid-19
- What exactly happens when supply chains have been changed?
- Is the drug supply being disrupted by covid-19?
- When could we see interruptions of drug supplies?
- Will our current efforts towards fighting covid-19 be enough to prevent breaks in the supply chain?
- Should we be concerned about the quality of medical products when non-medical companies are making medical equipment?
- Will this issue cause countries to re-evaluate medical imports?
- Will the supply chain model change forever?
- Where can companies find good references for how to evolve their current supply chain?
- Can companies streamline their process while maintain high quality?
Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.
Find Siegfried’s Book “Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers,” published in two volumes at DHI Books, the PDA Bookstore and Amazon.com
DHI Books – Volume 1 - http://dhibooks.com/books/17353.html
Volume 2 http://dhibooks.com/books/17354.html,
PDA Bookstore – Volume 1 https://www.pda.org/bookstore/product-detail/5145-good-distribution-practice-volume-1
Volume 2 - https://www.pda.org/bookstore/product-detail/5148-good-distribution-practice-volume-2
Amazon – Volume 1 - https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911386/ref=sr_1_2?dchild=1&keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&qid=1585932902&sr=8-2
Volume 2 - https://www.amazon.com/Good-Distribution-Practice-Healthcare-Manufacturers/dp/1942911394/ref=sr_1_1?dchild=1&keywords=Good+Distribution+Practice%3A+A+Handbook+for+Healthcare+Manufacturers+and+Suppliers&qid=1585932902&sr=8-1
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling the covid-19 pandemic.
This is the FDA enforcement policy that is discussed throughout the show. https://www.fda.gov/media/136449/download
Topics Include:
- How can we converse masks and respirators while demand is high?
- Will the influx of new masks and respirators be up to FDA standards?
- What is the FDA doing to halt counterfeit respirators?
- Will the quality of medical devices go down during this time?
- Is the US too late to effectively handle the demand?
- What are companies doing to conserve their products right now?
- How does this pandemic effect reliability testing?
- What will be the long term impact on medical device companies?
Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory guidelines and what goes into writing them.
- Why are the guidelines so important?
- What is the process for developing new guidelines?
- What is superior about the lifecycle approach?
- Why isn’t complying with Health Authority regulations enough to assure top quality?
- What would the industry do without Validation?
- What is a good business model to follow in this space?
Igor is the principal consultant at Valsouce Inc. He also is a Pharmaceutical and Biotechnology Industries’ Leader with broad strategic and tactical leadership experience spanning Development, Commercial Manufacturing, and Quality organizations. Proven record in implementing Validation Master Plans based on Risk Management and principles outlined in ICH Guidances Q8, Q9, Q10 and Q11 in variety of pharmaceutical facilities. Expertise in implementing Quality by Design in manufacturing environment throughout commercial product launch. Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA and other regulatory organizations.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals.
- What annex 1 actually is?
- What are the biggest changes from the previous version to the current document?
- What are some of the broad reaching impacts that annex 1 will have?
- What was lacking in previous versions, regarding contamination control?
- The distinction of viable counts and non-viable particle counts in this draft cause for concern.
- How will pharmaceutical companies produce the correct data based on the new verbiage in this document?
- How could this document affect the current processes in the lab?
- How will environment monitoring be changed moving forward?
- Will there be too many new steps for labs to monitor their clean rooms?
- Will we see more relaxed views on post sterilization integrity testing?
- Does Tim see this latest revision as an improved to the most recent draft?
Dr. Sandle is the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited (a pharmaceutical organization). Dr. Sandle is a chartered biologist (Royal Society for Biology) and holds a first class honors degree in Applied Biology; a Masters degree in education; and obtained his doctorate from Keele University.
Dr. Sandle has over twenty-five years experience of designing and operating a range of microbiological tests (including sterility testing, endotoxin LAL methodlogy, microbial enumeration, environmental monitoring, particle counting, bioburden, isolators and water testing). In addition, Dr. Sandle is experienced in microbiological and quality batch review, microbiological investigation and policy development.
Dr. Sandle is the editor of the Pharmaceutical Microbiology Interest Group Journal and runs an on-line microbiology website and forum (http://www.pharmamicroresources.com/). Dr. Sandle is an experienced auditor and frequently acts as a consultant to the pharmaceutical and healthcare sectors.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about staying compliant with compliant product compliant handling systems.
Stacey and Chris talk about a variety of topics:
- Overview of the type of systems and the current requirements impacting them
- How does this integrate into an existing QRM system and does it need to be managed by a separate implementation and monitoring team?
- What exactly constitutes a “product complaint” under regulatory standards?
- What are the most common errors or omissions?
- Outdated systems, Lack of information, and Poorly defined procedures. How can an organization overcome these challenges?
- What are all of the QMS components?
- What are three steps they can take to ensure compatibility with existing QRM?
- What are the best practices for companies to start their QRM?
- How often should internal audits be done of the product complaint process?
Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Voices in Validation
Why is it important to contribute to industry publications?
On this episode, Stacey Bruzzese is joined by Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Stacey and Paul talk about the need for more contributors to industry publications, not only for industry growth but personal growth as well.
- Why role did IVT originally serve?
- How to network between industry personnel and consultants?
- The differences between JVT and GXP
- What are some of the most impactful topics covered in JVT and GXP?
- How does IVT stay relevant in an ever changing landscape?
- Why does contributing to IVT help personal growth?
IVT has been around for more than 20-years. As its name suggests the purpose of IVT has always been to provide learning, networking and industry growth opportunities for professionals in the validation and compliance space. Over the years many things within the industry have changed, but IVT continues to work to expand the knowledge base for those working in FDA Regulated industries. Today we are going to chat with Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability.
- Roberta details the 8 essentials of DFM
- Why is Designing for Manufacturability important for medical device manufacturers?
- Does standardization of materials help shorten the product development cycle?
- What’s the next step after determining the practical part count?
- What is Poka-Yoke?
- What other points should be considered when scaling up manufacturing?
DFMA References
Assembly Automation and Product Design
G. Boothroyd, Marcell Dekker, Inc. 1992
Product Design for Manufacture and Assembly
G. Boothroyd and P. Dewhurst, G. Boothroyd Dewhurst, Inc. 1989
Marcell Dekker, Inc. 1994
Design and Analysis of Manufacturing Systems
Prof. Rajan Suri University of Wisconsin 1995
Product Design for Assembly: The Methodology Applied
G. Lewis and H. Connelly
Simultaneous Engineering Study of Phase II Injector Assembly Line
Giddings & Lewis 1997
Design for Manufacturing Society of Manufacturing Engineers,
(VIDEO)
Introduction to Design for (Cost Effective) Assembly and Manufacturing David
Steinstra, Rose-Hulman, 2015
IVT’s Medical Device Handbook: http://www.ivtnetwork.com/article/medical-device-validation-handbook
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israel. Stacey and Karen talk about what’s new with global systems and regulatory guidelines.
What’s new in Quality Management System
- For Virtual companies, what are their responsibilities in terms of quality systems?
- What’s the new EU guidance around vendors and responsibility?
- What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness of a Pharmaceutical Quality System?
- What are the differences in protocols for QRM systems in digitally enabled and fully automated labs?
- What’s happening with Annex 1?
More information on the topics discussed can be found at:
ISO 18091:2019
Quality management systems — Guidelines for the application of ISO 9001 in local government
https://www.iso.org/standard/72808.html
Validation Week 2020
http://www.cbinet.com/conference/pi20083
FDA Information on PQS
https://www.fda.gov/media/92818/download
ICH Q10 Quality Management
https://www.fda.gov/media/71553/download
IT and Computerized Systems Conference
http://www.cbinet.com/conference/pi20045
ICH guideline Q10 on pharmaceutical quality system
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002871.pdf
ICH guideline Q9 on quality risk management
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002873.pdf
Karen has over twenty years of experience in the pharmaceutical industry. ... After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years.Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. They discuss change management and the variety of factors that contribute to successful implementation.
- What is included in a solid change management SOP?
- What are the best practices for identifying level of risk to products or systems?
- What is the best way to handle changes that are urgent, planned or temporary?
- What best practices exist for pre-approvals to changes in a like-for-like change scenario?
- Siegfried provides insights into streamlining the requirements of the change control process
- Siegfried shares some examples of GMP deficiencies and the specific findings
- What are the most important takeaways from the discussion?
Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide variety of change control topics.
- Alan gives a brief review of the product lifecycle
- When does change control start and end for a product?
- What should be included in change control SOP?
- Is the process of change control vastly different during development and post market?
- What are the key drivers for post-launch changes?
- What is unique about the review and documentation processes for post launch?
- What differs between pro-active versus reactive changes?
- What tools can be used for identifying the true effect of a change?
- What are the most common pitfalls to change control compliance?
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. They discuss how to avoid blind spots when it comes to data integrity.
- What systems and processes need to be included in my Data Integrity program?
- Who is responsible for oversight?
- Siegfried talks about a common misconception about electronic data
- Are informal notes and brainstorming sessions part of the data integrity equation?
- Why are so many of us not adhering to our own internal policies?
- How can I increase awareness to potential data integrity issues?
- Stacey and Siegfried discuss violations in conduct
- What is managements role in these cases?
- Siegfried shares some strategies for identifying hidden issues
Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since 2007. He is a Thought Leader in Competitive Compliance, Data Integrity and Supply Chain, as well as a trusted expert for regulatory, compliance and industry-best-practices projects. Siegfried has more than 30 years’ experience in the healthcare industry, spanning manufacture, analytics, validation and quality assurance. He received his Ph.D. in Organic Chemistry from the University of Berne, Switzerland and is a Fellow of the Royal Society of Chemistry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com
On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. They discuss a variety of aspects around the topic of data integrity.
- Why are we hearing more about audits and audit reviews lately?
- Ivan talks about the history of audit trail reviews and the current challenges
- Why are audit trails important to safety, efficacy and reliability or pharmaceuticals and how does that impact data integrity efforts?
- Why is it important to assess the products’ entire legacy or history?
- Ivan shares advice on the frequency of periodic reviews and what should be included in those reviews
- He shares some tips for simplifying the review process
- Where does Ivan see the industry moving regarding audit trails?
Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com
On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a recent IVT conference and was facilitated by Alyce Deegan, Vice President of Data Integrity at Compliance Path LLC.
- What factors impede a zero-findings review?
- How can I prepare for an audit review?
- What can I expect from the inspectors?
- What kinds of questions do they ask?
- What is the best way to answer these questions?
These questions and more are covered during the mock audit. This episode has a lot of useful tips for anyone preparing for an audit. For additional information about Alyce’s presentation got to http://www.ivtnetwork.com/article/data-integrity-mock-inspection-mitigating-risk
Alyce Deegan has over 20 years of experience in Pharmaceutical, Medical Device and Gene Therapy industries. Most recently, Alyce was the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA. Throughout Alyce’s career she has held leadership positions in Quality, Validation and IT at companies such as Pfizer, Biogen and ThermoFisher. Throughout her career she has built and continues to build "Unified Compliance Models" within companies to address the ever changing regulations and has been directly involved with multiple agency inspections throughout the years.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey back to talk about testing automation and how new technologies impact Computer Systems Validation (CSV).
Stacey and Valarie cover a variety of topics:
- With Parma moving toward AI, IoT, Big Data and more, what are some of the trends specific to Computer Systems Validation?
- Over the next 12 months, what are some of the greatest obstacles to full integration of technologies for pharma companies?
- How do manufacturers choose between on-site servers, private cloud and public cloud options?
- What does the hosting choice mean for Cybersecurity professionals supporting the life science space?
- What will the impact be on traditional Computer Validation best practices?
- What does an integrated solution look like, and what steps must industry leaders take to move in the right direction?
- What parting thought does Valarie have for the listener?
Valarie King-Bailey, is CEO of OnShore Technology Group –a Chicago-based global IV&V firm. Valarie has over 30 years of validation experience in the engineering and life sciences disciplines. She has conducted validation exercises for leading life sciences companies across the globe. She holds a B.S. in Civil & Environmental Engineering from the University of Wisconsin -Madison and an MBA in Information Systems from Keller Graduate School of Management. She received a lifetime achievement award from the University of Wisconsin College of Engineering and is a UW College of Engineering Distinguished Alumni.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processes and computer systems – both hardware and software.
Stacey and Chris talk about a variety of topics:
- Chris gives a brief overview of CSV and why it’s important to the integrity of the product
- Chris explains why, in an FDA regulated laboratory, CSV is not only concerned with computer hardware and software
- What is the impact on the Pharma industry of going paperless and relying more on computer documentation?
- What are some of the biggest hurdles for compliance?
- What are some of the best practices for big data and data integrity?
- How will implementing more technologies like IoT and AI impact CSV?
- Where does Chris see things heading in the future?
Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the final part of our 3-part series. Stacey and Roberta review the steps necessary for a successful product launch.
Stacey and Roberta cover a variety of topics:
- Roberta outlines the steps associated with the final phase prior to product launch
- Do you still need to be thinking about verification and validation?
- Is this the right time to be thinking about marketing and branding?
- What data are you looking for with a product release into Limited Test Markets or Clinical Trial Sites?
- How thorough should your completed technical documentation need to be prior to full product launch?
- Roberta reviews all that is needed to fully launch the product
- What does the post-market surveillance entail and how long does it take to complete?
- What are the best practices for capturing this data?
- How does cloud-based computing affect the requirement for maintaining post-market data integrity?
- What kinds of problems could occur after product launch?
- Roberta talks about how listeners can make use of the information presented in this 3-part series
The following links have useful companion information for this episode:
Post-Market Requirements:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices
IVT’s Medical Device Validation Handbook:
http://www.ivtnetwork.com/article/medical-device-validation-handbook
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series. Stacey and Roberta dive into the design and development of medical devices.
Stacey and Roberta cover a variety of topics:
- What are the tasks that make up the design and development phase?
- Do people develop prototypes and when is the right time to do that?
- How is human factors design applied to engineering medical device?
- What records and documents need to be considered during the design and development?
- How do Design for Manufacturing and Six Sigma get incorporated?
- Roberta highlights the typical challenges when planning for packaging, labeling and product delivery
- What’s the difference between validation and verification?
- How does managing compliance through the risk management cycle help ensure quality and safety are built into the product?
- How do labeling requirements affect the expiration date?
The following links have useful companion information for this episode:
FDA Labeling (General)
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
UDI System:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
Investigational Device Exceptions:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812
Test method validation article on IVT Network:
http://www.ivtnetwork.com/article/test-method-validation-medical-devices
http://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidance
Method Validation Guidelines:
https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines
Design Controls:
https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market.
Stacey and Roberta cover a variety of topics:
- Roberta start by outlining the steps covered in this first episode
- How do we ensure we’re building a product the meets a clinical need?
- What goes into a product launch plan?
- What are the considerations if you plan to introduce the product outside of the United Sates?
- Why do investors need to be aware of how regulatory bodies classify your product?
- How does the business plan for a medical device differ from other products?
- What should be included in an initial risk management plan?
- What are the key elements to streamline the funding process?
- Should I try to fund the full project or just the first few phases/milestones?
The following links have useful companion information for this episode:
EU Medical Device Standards: http://eumdr.com/
Risk management Standards: ISO 14971 - https://www.emergobyul.com/services/worldwide/iso-14971-consulting
EU Directory: https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9p
FDA: CDRH Guidance: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development
Searchable product classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
FDA Good Guidance Practices: https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pc
Funding Resources
FDA 510(k) Premarket Submission https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Felicia Ford-Rice from PAREXEL Consulting to talk the top 3 trending topics in pharmaceuticals – data integrity, AI and leadership.
Stacey and Felicia talk about a variety of topics:
- Felicia talks about the importance of data integrity in pharmaceuticals and why it remains a burning issue
- How do data integrity and security impact the manufacturing process, operations and clinical environments?
- What are the pros and cons of pharma adopting artificial intelligence?
- Where are we in the adoption cycle on AI implementation and how does it look going forward?
- Will AI help the success rates of drugs passing clinical trials?
- Are the leadership roles within pharma changing and how so?
- What skills and strengths will be needed for leaders going forward?
- What steps do industry leaders need to take to move in the right direction while still emphasizing a patient centric mindset?
- MIT study - https://academic.oup.com/biostatistics/article/20/2/273/4817524
Felicia Ford-Rice utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation, and management of quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: GxP Compliance/ Inspection Readiness / Training, Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control Evaluation, and Corrective Action and Preventive Action /Product Complaint Assessments. She achieved a master’s in Bioscience Regulatory Affairs from Johns Hopkins University, as well as a Master’s of Management in Business Administration and a BS in Biology from Virginia Tech.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey to talk about women in Technology, Engineering and Mathematics.
Stacey and Valarie talk about a variety of topics:
- Valarie talks about her experience at the Women in Validation Empowerment Summit that she attended during Validation Week.
- Valarie discusses what she believes keeps women from pursuing careers in the engineering field
- How does Valarie interpret the statistics that show women earn less than men in engineering and whether women need to prove themselves repeatedly to get the same recognition and respect as men
- What make Valarie different from the 70% of women who earned bachelor’s degrees in engineering but have since left the industry?
- Does direct dialog backed by data earn women credibility in the workplace?
- How does Valarie view the low numbers and women in leadership positions and what can be done to change this?
- What can leadership teams do to create a more consistent and unbiased plan for promoting women in STEM?
Valarie King-Bailey, is CEO of OnShore Technology Group –a Chicago-based global IV&V firm. Valarie has over 30 years of validation experience in the engineering and life sciences disciplines. She has conducted validation exercises for leading life sciences companies across the globe. She holds a B.S. in Civil & Environmental Engineering from the University of Wisconsin -Madison and an MBA in Information Systems from Keller Graduate School of Management. She received a lifetime achievement award from the University of Wisconsin College of Engineering and is a UW College of Engineering Distinguished Alumni.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Karen Ginsbury to talk about Pharma 4.0. They talk about what Pharma 4.0 is all about.
Stacey and Karen talk about a variety of topics:
- What exactly is Pharma 4.0?
- Have we reached or passed the tipping point for adoption?
- What is included in Pharma 4.0?
- What obstacles does Karen see for implementation of Pharma 4.0?
- Karen gives a 2-minute explanation of whether Parma 4.0 is affordable and efficient
- Does Karen think people will be worried that they don’t understand how Pharma 4.0 works?
Karen Ginsbury is President and CEO of PCI Pharmaceutical Consulting. She has over twenty years of experience in the pharmaceutical industry. After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel, Ltd. Which has been providing services to the pharmaceutical industry worldwide for the past 13 years.
Below are some links to help understand Pharma 4.0 topics:
TESLA
https://www.cnbc.com/2019/05/20/wedbu...
4th industrial revolution-Future of Health & Healthcare
https://www.weforum.org/platforms/sha...
Future of Advanced Manufacturing & Production
https://www.weforum.org/platforms/sha...
Future of Artificial Intelligence and Machine Learning
https://www.weforum.org/platforms/sha...
Credit Suisse article
https://www.credit-suisse.com/about-u...
Novartis Smart Factory
https://www.novartis.com/stories/disc...
FDA Doc:
https://www.dropbox.com/preview/cbi/I...
Pioneering Perspectives:
https://www.dropbox.com/preview/cbi/I...
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Matthew LaPierre to talk about Audit Trails. Matthew is a data integrity industry expert.
Stacey and Matthew talk about a variety of topics:
- Many Pharma companies view audit trails as the Wild West. Matthew talks about the current landscape of audit trails in Pharma
- In an atmosphere where everything is computerized and we have AI and Big Data, why is the industry having such a challenging time tracking and maintaining audit trails?
- How do audit trails help in the areas of safety, efficacy, the reliability of pharmaceuticals and ensuring patient safety?
- Matthew provides some tips for simplifying the audit trail process
- How are improved technologies and systems making data mapping easier to implement?
- Where does Matthew see the industry moving on audit trails and what can companies do to get started today?
Mr. LaPierre is an experienced data integrity program manager and industry expert in the field. He has a thorough understanding of not only the foundation and principles of data integrity, but the project management tools and resources needed to execute a truly effective data integrity program at a pharmaceutical site. He is currently engaged worldwide, speaking at conferences and helping companies build programs from the ground up.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese welcomes Steve Thompson, Director Computer Quality Assurance for Science 37.
Stacey and Steve talk about a variety of topics:
- Why is the FDA’s Case for Quality which launched in 2011 just now being implemented on a more widespread level?
- What challenges are posed by implementation?
- Steve walks through the core components of the Case for Quality
- Although it will roll out as a voluntary pilot program, what does Steve see as the progression over the coming months and years?
Mr. Thompson has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
This week, Stacey talks to Natalia Locatelli. Natalia is a Conference Producer at CBI. They discuss what it takes to put together IVT Network’s Lab Week.
Stacey and Natalia cover a variety of topics:
- How do you find the right content, venue and location for a conference?
- What is the process for determining the best topics for presentations and workshops?
- Natalia is currently working on lab week. For more information check out the links below:
- http://www.cbinet.com/conference/pi19081
- http://www.cbinet.com/sites/default/files/brochures/pi19081_brochure.pdf
- How does Natalia collect and apply feedback from the conferences?
- What are the challenges in creating content for the compliance and regulatory industry?
- How can speakers, sponsors and exhibitors get involved?
Natalia has worked in marketing and communication for over ten years. She went to Emerson for a Master’s in Publishing to pursue her passion for bringing attention to great books and messages. When she joined Informa Connect, she brought her experience with business research, communication skills, and project management together to bring that same level of focus and interest to the life sciences conferences that she produces.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
On today’s episode, Stacey Bruzzese talks to Dr. Tim Sandle, the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited.
Stacey and Tim cover a variety of topics:
- For pharma manufactures, how does fewer employees, smaller inventory, less space and reduced time impact patient safety?
- What type of supplier oversite is necessary?
- As supply chains become more and more digital, how does IoT impact processes and programs controlling quality?
- How do Big Data and Cloud Computing relate to patient safety, accessibility and affordability?
- What does Dr Sandle see as the next major shift in supply chain migration?
Dr. Tim Sandle is Head of Microbiology and Sterility Assurance at Bio Products Laboratory, responsible for microbiological testing, microbiological R&D, risk assessment and contamination control. In addition, Tim is a tutor with the University of Manchester School of Pharmacy (lecturing on pharmaceutical microbiology) and with University College London Pharmacy School (training QPs in sterility assurance). Tim is a committee member of the pharmaceutical microbiology group Pharmig (since 2002) and he has been contributing to the IVT Network since 2006. Tim presents and writes regularly on microbiology and pharmaceutical science topics, with 15 books; and some 600 book chapters, peer reviewed papers and technical articles to his name.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.