The Qualitalks Podcast: Recent Episodes
Qualistery
The pharmaceutical industry is a fascinating and complex field. It takes countless of people to bring a product to the market. In the Qualitalks Podcast, I bring to you experts, leaders, and innovators who will explain to us how they do it! We will talk about GMP, quality, manufacturing, business, and much more.
Yan Kugel is joined by Christy Mazzarisi, a distinguished leader in the pharmaceutical industry with extensive experience in quality systems and leadership roles. In this episode, we explore Christy’s journey in pharma, her works, her impact on advocacy and leadership, and her vision for empowering women in the pharmaceutical industry. [...]
Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She’s the founder of the QneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing [...]
In this episode, Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She's the founder of the QneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends across the years with Simone.
Yan Kugel is joined by Ben Coverdale, PhD, a seasoned global account director at Patsnap with a strong background in the life sciences and innovation and intelligence sectors. Ben brings a wealth of experience and insights into how AI and LLMs (Large Language Models) are transforming patent research and analysis [...]
Yan Kugel is joined by Pavan Pasupulati, the Vice President of Manufacturing Excellence at Caliber Technologies. Here, he shares valuable insights into the future of pharmaceutical manufacturing. With over 25 years of experience in both the process and IT industries, Pavan has become a key figure in driving digital transformation [...]
Yan Kugel is joined by Vincent Cafiso, the Director of Quality and Regulatory Services at CERO Consultancy and a former FDA investigator. Vincent shares invaluable advice on things never to say to an FDA investigator based on his extensive experience and expertise in the field. Vincent’s Background as an FDA [...]
Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding [...]
In this episode, Yan Kugel is joined by Mohamed Amer, a seasoned executive with over 20 years of experience in strategic and commercial leadership in the healthcare industry. Mohamed emphasizes the significance of CME (Continuing Medical Education) accreditation when promoting pharmaceutical products. He further discusses the challenges companies face in different countries regarding ethical standards and regulations when promoting pharmaceutical products.
In this episode, Kelly discusses her experiences in the pharmaceutical industry and the challenges of implementing cloud-based software tools. She also shares insights on improving processes and the impact it has on an organization.
In this podcast episode, Nagesh Nama shares his expertise in incorporating AI into validated processes within the pharmaceutical industry. He discusses the benefits, challenges, and best practices of using AI and machine learning technologies in pharmaceutical manufacturing quality.
Yan Kugel is joined by Lesley Worthington, a communication and leadership coach for quality professionals, to discuss the importance of interpersonal skills in quality assurance within the pharmaceutical industry. Lesley highlights the often overlooked yet crucial role of communication and interpersonal skills in the success of quality professionals, emphasizing the [...]
Vasyl shares his expertise in integrating AI solutions into the pharmaceutical industry and the practical implications of driving innovation and growth. The conversation delves into the use of AI and machine learning models in pharma, including the application of large language models like ChatGPT and GPT-3 for employer education and [...]
Vivek shared his wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within the pharmaceutical manufacturing industry. Throughout the episode, Vivek delved into the transformative impact of AI on manufacturing, QA, and QC processes, shedding light on how these advancements are revolutionizing productivity and adherence to CGMP [...]
Jakob Konradsen, the co-founder and head of quality at Eupry emphasized the importance of data integrity and advanced statistical analysis in the pharmaceutical industry. He discussed the challenges related to temperature control and highlighted insights that can benefit GMP professionals. Jakob's journey from an electrical engineer to an entrepreneur in [...]
Paul shares his wealth of experience and insights into innovative strategies and best practices for maintaining quality standards and regulatory compliance in the pharmaceutical supply chain. The discussion delves into the evolving landscape of GDP and the key insights gained from Paul's recent projects in the industry. The conversation also [...]
In this episode, we welcome Jennifer Chang, a QA Intelligence Specialist at Blue Mountain. Yan Kugel and Jennifer discuss the impact of digital transformation on manufacturing processes, the challenges and benefits of compliance in the pharmaceutical industry, and companies' struggles in keeping up with regulators and taking a risk-based approach. They also explore why companies switch to digitized solutions and the importance of continuous learning in the pharmaceutical industry.
abrizio Manilio discusses the role of digitalization and AI in the life sciences industry. He shares insights into the future of technology, the importance of understanding capabilities, and the potential impact on patient outcomes. Tune in for a fascinating conversation on the cutting-edge advancements in AI and digitalization.
In today's episode, we have a special guest, Harsh Thakkar, who has made a successful journey into consulting within the pharmaceutical industry. Harsh is a seasoned professional with extensive experience in advising on GXP practices and regulatory compliance. His career in consulting in the life science field is filled with insights, challenges, and triumphs that have shaped his career and made him a respected figure in the industry.
The podcast is brought to you by Qualistery, a leading provider of webinars, training, and consulting for the pharma industry.
For business inquiries, get in touch at info@qualistery.com.
Yan Kugel is joined by Amar Badwy, the CEO at Pharmaoffer, to discuss digitalization in the pharma industry and the trends in the API market. They talk about the changes and challenges in the industry, the importance of personal relationships in business, and the need for a more approachable and visible online presence for API manufacturers. They also discuss the impact of the pandemic on digitization and the evolution of Pharmaoffer as a marketplace for APIs and service providers in the pharmaceutical industry. The conversation provides valuable insights for API manufacturers and pharma companies looking to connect and do business.
Episode Chapters:
- Introduction and background (0:00 - 2:45)
- Changes and trends in the API market (2:46 - 8:30)
- Insights from analytics and understanding market needs (8:31 - 15:22)
- Focus on the contract services market (15:23 - 19:40)
- Acceptance of data sharing and challenges (19:41 - 25:10)
- Connecting service providers in the pharma industry (25:11 - 30:45)
- Conclusion and future plans (30:46 - 34:20)
The podcast is brought to you by Qualistery, a leading provider of webinars, training, and consulting for the pharma industry.
For business inquiries, get in touch at info@qualistery.com.
Join us as we dive into an insightful conversation with Toon Lambrechts, the Co-Founder of MyCellHub, in an exploration of advanced therapies and the democratization of access to life-changing treatments.
In this podcast episode, Yan Kugel interviews Nathan Roman about the importance of temperature control in the supply chain industry, specifically in the cold chain.
In the latest episode of Qualitalks, Yan Kugel and Nathan Roman dive deep into the world of qualification protocols and share their insights on writing effective ones.
In this episode, Nathan Roman shares his knowledge of the different steps and regulations when validating a temperature-controlled chamber.
In this podcast episode, Nathan Roman, one of the top experts in Temperature control mapping, speaks about thermal mapping and its importance for pharmaceutical compliance.
Steve Galen has been involved in clinical trials for more than 27 years now, in various high-level positions. In this podcast episode, he will explain the different stages of the clinical trials and point out the most severe deficiencies in the industry and how to overcome there.
By listening to this episode of watching it, you will learn about:
- What is a clinical trial, and what's the main goal?
- What are the questions asked in clinical trials protocols?
- What are the parts of a clinical trial?
- How are those parts connected to the primary goal?
- What are the most common challenges with clinical trials nowadays?
- How can we make clinical trials more transparent and predictable?
- What are the goals of VC-funded biotech in early-stage clinical development versus pharma in later-stage clinical development, and how are these goals related to the primary purpose of a clinical trial?
Watch or read the full podcast and read the article at https://podcast.qualistery.com/what-are-clinical-trials-and-and-how-to-solve-its-biggest-challenges
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast episode, our guest is Chris Maughan, a Sterilisation and Validation Consultant.
Chris has spanned over 16 years with areas of expertise including validation compliance and consultancy support and training across Europe, the Middle East, Asia and the USA.
In this episode, you will learn about:
- What is the role of autoclave sterilization in the pharmaceutical industry?
- What are some of the significant types of autoclaves in the market?
- How to choose an autoclave for your needs?
- How would you go about choosing a good vendor for autoclaves?
- What should go in the URA for autoclaves?
- What to check through all the qualification steps?
- What routine tests should you run on autoclaves daily?
Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-choose-and-qualify-autoclaves-and-what-pitfalls-to-avoid
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
Excipients are an integral part of any pill, and they are becoming more complex with time. The complexity plays a significant role from the regulatory aspect and their role in the drug's function.
In this podcast episode, our guest is Philippe Tschopp. Philippe is a Business Developer at Glatt Pharma and an enormous Excipient enthusiast.
Because of his passion, he found the website www.pharmaexcipients.com, where they post scientific insights about developments in the excipient world.
In this episode, Yan Kugel interviewed Philippe about the ever-changing excipient landscape and its role in drug manufacturing.
Listing to the podcast, or watching the video, among others, you will learn about:
- What makes excipients such an exciting field
- How pharmaexcipients.com was born, and what is its purpose?
- Where is the excipient market heading?
- What should change in the excipient world?
- What can be achieved by choosing the most optimal excipient for the novel drug?
Watch or Listen to the full podcast and read the article at https://podcast.qualistery.com/how-is-the-excipient-world-evolving
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast episode, our guest is Troy Fugate, a pharma industry and GMP veteran with 30+ years of experience in the field. Now, he is the Vice President at Compliance Insight, Inc. They help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing innovative drugs, medical devices, and biologics.
Troy believes that the single most challenging issue leaders face is incorporating GMPs into their company culture. The leaders don't know how to blend GMPs into their mission and vision with the right passion. Only then can employees see the whole vision and understand the "Why". Not just to do things because "it's required by the GMPs" but to see the value in those actions.
Listening to the podcast or watching the clip, you will learn:
- How to establish a unified quality mission across a pharma organization
- Why some people see GxP as a hurdle, and how to change that
- Why using KPIs wrong can cost you your best employees
- How to Deliver Effective and Measurable GMP training
Watch or read the full podcast and read the article at https://podcast.qualistery.com/infusing-gxps-into-your-organizations-dna
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast episode, our guest is Marc García Gómez, a pharmaceutical contamination control strategy consultant. He is also the author of various articles in Spanish pharmaceutical magazines about cleaning and disinfection. During their talk, Marc discussed with Yan Kugel about the EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products draft and how it would affect pharma companies and their current contamination strategies.
Here are some of the things you'll learn about listening to or watching the podcast:
· A new dawn for microbiologists in the pharmaceutical industry
· What critical ideas Annex one introduces
· What new roles will the Maintenance department, upper management, and operators will have
· The importance of validating aseptic agents
· How to start preparing for the Annex 1 launch
Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-will-the-revised-annex-1-impact-your-contamination-control-strategy
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, Yan Kugel and our guest Jerry Chapman talk about how the landscape has changed over the years in the Pharma industry and what things have remained the same. In this episode, they discuss technological advancement in the pharmaceutical industry, what holds us back, and where we are headed.
Who is Jerry Chapman?
Currently working as Senior GMP Quality Expert at Redica Systems, Jerry has invaluable experience in the quality domain and implementation of international GMP regulations in quality policies. With experience spanning 40 years, he is helping to develop coursework on manufacturing deviation investigations and teaching the course to enable the personnel to conduct and properly document investigations.
Watch or read the full podcast and read the article at https://podcast.qualistery.com/why-we-need-new-technology-in-gmp-and-what-stops-us
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, our guest is Jerry Chapman, a GMP expert with more than 40 years in the industry. Jerry and Yan talk about what has changed in pharma over the years and what has remained the same. He discusses the development of new courses as well as the importance of leadership training in the companies.
Who is Jerry Chapman?
Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years of experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. At Redica Systems, Jerry works with the machine learning and data science teams. They build computer models that examine enforcement actions and produce analyses the way an expert would in the past using hard copy documents and a highlighter. He is also an author of many articles detailing and analyzing current hot topics among the pharma industry, and international regulators appear on the Redica Systems Conference Spotlight page.
Listening to the podcast, you will learn about:
● The Evolution of Pharma Industry
● FDA Training Requirements
● Required Skills in Quality Domain
● Why Generalists are a Bad Thing
● Better Methods for Training Experts and Leaders
Watch or read the full podcast and read the article at www.podcast.qualistery.com/things-that-have-to-change-in-gmp-to-drive-success
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, Yan Kugeland our guest Megann Löffler talk about the new trends in the pharmaceutical industry, what you need to know about the market and what the companies are looking for. Her experience in the recruitment field enables her to give valuable insights that will potentially help you to build a successful career in the future.
Who Is Megan Löffler?
With an educational background in engineering coupled with an HR degree, Megann is currently working as a Talent Acquisition Manager at Headcount AG. It is a Zürich based consultancy serving clients in the pharmaceutical and biotechnology market segments. Megan has been working as a recruiter for six years, specializing in Pharma since the very start of her career. She is now building up her team within headcount and embracing management responsibilities and technical operations positions.
Listening to the Podcast, You Will Learn About:
● Innovations in the Pharmaceutical Industry
● Effect of New Developments on Recruiting Process
● Challenges for the New People in the Industry
● What Are Pharmaceutical Companies Looking for?
Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-to-build-a-successful-career-in-the-pharma-of-tomorrow
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, Luis Charles Chavarría shares his invaluable insights from his 30-year career in the FDA. He explains how the FDA really operates, their main purpose during an audit, and sheds light on details you have probably never known about the FDA.
Who Is Luis Charles Chavarría?
Luis has served in FDA for about three decades in several capacities that have earned him an unprecedented understanding of FDA affairs. He is currently working as President/Lead Consultant at Supaso International. He has also worked with the US Department of Justice and contributed to policymaking at the national as well as on the international level.
Reading the Article and Listening to the Podcast, You Will Learn About:
● What Does an FDA Agent Do?
● Difference Between an FDA Investigator and a Regular Quality Auditor
● Evidence Development by an FDA Investigator
● Procedures for Foreign-Based Manufacturing Units
Watch or read the full podcast and read the article at www.podcast.qualistery.com/guide-to-preparing-yourself-for-an-fda-audit/
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, we have with us Yan Leyfman, MD. We will discuss and ask Dr. Leyfman about his views regarding how medicine and medical research will look in the future and the role of Artificial Intelligence and Personalized Medicine in disease treatment and the future of medicine. We will also ask Dr. Leyfman about some of his extraordinary career and life experiences.
Who Is Yan Leyfman?
Yan Leyfman, MD, is a medical doctor and a passionate researcher. His areas of command and interest are immunology, and oncology, i.e., the study of cancer. He is a survivor of the Chernobyl Nuclear Disaster in the USSR, and this incident deeply connects with his career and life ambitions.
Listening to the podcast, you will learn about:
● Dr. Leyfman's Career Inspiration and His Services in COVID-19 Pandemic
● What Factors Hinder Progress in Medical Research?
● Role of Artificial Intelligence (AI) in the Future of Medicine
● What Does the Future of Personalized Medicine Look Like?
● What Could Be the Next Breakthrough in Medicine?
● COVID-19 Pandemic for the Future of Medicine
Learn More About GMP at www.qualistery.com.
Watch or read the full podcast and read the article at www.podcast.qualistery.com/how-does-the-future-of-medicine-look-like/
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, we talk about CMOs and CDMOs, i.e., Contract Manufacturing Organizations.
What they are, how they work, their past and expected future, and everything you need to know about them as a startup, a company, or just as an individual.
Our highly experienced and knowledgeable guest for this session is Kurt in Albon.
Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for more than 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.
For this special episode, co-hosting alongside Yan Kugel is Ammar Badwy. Ammar is CEO and co-founder at Pharmaoffer, an online business-to-business platform for pharmaceutical ingredients.
In this podcast, you will learn:
● What are CMOs or CDMOs and what do they do?
● History of CMOs - How long have they been there?
● How to find the right CMO/CDMO?
● How does a contract manufacturing organization earn?
● What is the future of contract manufacturing?
● Some more interesting information about CMOs/CDMOs
Learn More About GMP at www.qualistery.com.
Watch or read the full podcast and read the article at podcast.qualistery.com.
This episode is Sponsored by Dot Compliance, the industry’s first ready to use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, Yan Kugel and our guest Rizgar Saltik talk about networking, branding, and marketing using LinkedIn, arguably the best online platform for professionals and business interactions. They also discuss using LinkedIn marketing to grow a robust business network as a pharma company, business, or independent entity.
Who Is Rizgar Saltik?
Currently working as a partner and consultant at Sciential, Rizgar is life sciences and health entrepreneur specializing in Digital Marketing and Consultancy. He has an educational background in Neurobiology and Business Management. Rizgar has been behind the success of more than 25 medical technology and biotechnology-related product launches and their commercialization.
In This Blog Post, You Will Learn:
● Why Are More People Using LinkedIn Now?
● How to Use LinkedIn for Networking?
● How to Use LinkedIn for Personal Branding?
● How to Use LinkedIn Marketing for Growing Your Business?
Watch or read the full podcast and read the article at https://podcast.qualistery.com/how-to-use-linkedin-marketing-to-grow-a-powerful-business-network/
Ask questions and learn about GMP here: www.qualistery.com.
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier. Learn more about them here: https://is.gd/l8BTWt
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast with Kurt In Albon, we will look at the concept of true leadership and its importance in the pharmaceutical industry. Kurt will tell us what essential qualities are required to be a successful leader, what pharma companies should look for when hiring talent, and some valuable tips for people who aspire leadership.
Who is Kurt In Albon? Kurt is Global Head of Information Quality at Lonza, one of the biggest CMOs in the world. He has been in the pharmaceutical industry for over 25 years and holds leading-edge expertise in data integrity, pharmaceutical validation, international team management, and computer science.
In this podcast episode you will learn: ● What Is Leadership and Why Is It Important in the Pharma Industry?
● How Is a Leader Different From a Manager?
● What Should Companies Look For in Employees When Hiring?
● Situational Leadership in Pharmaceutical Industry: Does That Work?
● How Can You Become a Good Leader in the Pharmaceutical Industry?
Watch or read the full podcast and read the article at podcast.qualistery.com.
Ask questions and learn about GMP here: www.qualistery.com.
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, we have Philippe Tschopp from Glatt Pharmaceutical Services, a specialized CDMO. We will discuss with Philippe about CDMOs, what they are, how they work, and what a customer should look for in them. We’ll also ask him about Glatt Group as an example of how CMDOs work.
Who is Philippe Tschopp?
Philippe is the head of business development at Glatt Pharmaceutical Services. He has solid experience of well over a decade in business, sales and B2B digital marketing. He is also hugely enthusiastic about excipients and solid dosage forms.
Introducing our Co-Host:
Co-hosting this session alongside Yan Kugel is Ammar Badwy. Ammar is CEO and co-founder at Pharmaoffer, an online business-to-business platform for pharmaceutical ingredients.
In this blog post, you will learn:
● What is a CDMO and what it does?
● Glatt Group as a CDMO
● How to choose the right CDMO
● How Glatt Group deals with a project as a CDMO
● The trend of CDMOs in the near future
Learn More About GMP at www.qualistery.com.
Watch or read the full podcast and read the article at podcast.qualistery.com.
This episode is Sponsored by Dot Compliance, the industry’s first ready-to-use Quality Management Solution powered by the SalesForce platform. Implementation of a new eQMS has never been quicker nor easier.
Pharma #GMP #Pharmaceutical #Pharmaceuticalmanufacturing
In this podcast, Yan Kugel and our guest, Àngels Llarch, talk about how pharma companies should host external audits. Àngels shares some really insightful tips regarding hosting an audit, coming right from her 20 years of vast experience in the pharmaceutical industry.
Who's Àngels Llarch? Currently working as API Compliance Head/Deputy RP at IMCD Switzerland AG, Àngels has more than two decades of solid experience, working in the Quality domain for several renowned pharmaceutical suppliers. She loves audits as they serve as a tool to discover new ways of implementing good manufacturing practices across the industry.
In This Podcast Episode, You Will Learn: ● What is an audit, and why is it performed?
● Do audits lead to the opening of pandora's boxes?
● How to prepare for an external audit
● Golden rules for hosting external audits by Àngels Llarch
● How to build trust with your auditor
Learn more about GMP on www.qualistery.com
Watch, listen or read the article on podcast.qualistery.com
Christy Mazzarisi is the Global Lead of Quality at CGI, supporting clients with automation quality systems.
In this episode, Christy talks to Yan Kugel and sheds light on the complex world of pharmaceutical automation and AI.
Listening to or watching this Qualitalks Podcast episode, you will learn about:
- What is the difference between intelligent automation (IA) and Artificial Intelligence (AI)?
- What is the value of AI and IA to pharmaceutical quality?
- How much money, time, and resources can AI and IA systems save for an organization?
- How to build and implement proper AI and AI networks?
- What are the challenges and the solution for AI and AI implementation?
Watch the full video episode on podcast.qualistery.com
Learn more about GMP on www.qualistery.com
Find GxP consultancy work on www.paragonspoint.com
Yuval Shapiro is the founder of Quality with Value Ltd. A company that provides QA/RA for Medical Devices Services.
Yuval is a Quality Assurance & Regulatory Affairs Expert and consultant for products and companies primarily related to medical devices and telecom sectors. Additionally, he is a black belt Six Sigma certified from Johnson & Johnson.
In this podcast episode, he discusses with Yan Kugel the history and evolution of Quality and why we are witnessing the death of Quality in his opinion. Then, he explains how to save it!
Watch the full video episodes on podcast.qualistery.com
Learn about quality and GMP for the top experts in the industry at www.qualistery.com
Suzzane Studinger has been a GMP consultant for over 9 years now. In this podcast episode, she explains why she decided to leave her steady job by Roche to become an independent consultant. She also reveals what the REAL job of the consultant is, what the challenges are behind it, and gives advice for employers for making the best of their consultants.
Watch the full video episode here.
James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharmaceutical and biotech sectors, James has experience consulting companies in other highly regulated industries such as Automotive and Fintech.
In this podcast episode, James spoke to Yan Kugel about CSV and its essential parts, about which you don't learn in training.
Here are some of the topics you will hear about:
- The most challenging parts of CSV are not what you think they are.
- The real objectives of CSV.
- What's more critical in CSV than CSV?
- What is the role of the QA in CSV?
- What are the functions of the CSV lead?
- How to manage sake holders?
- The reasons why companies should hire external CSV leads.
Watch the full video episode on podcast.qualistery.com.
Master GMP on www.qualistery.com.
"QA is a service provider and not a slave of the regulations."
-Yaron Ziv
Yaron is a pharmacist and the Head of QA at Chemipal, a medicinal distribution service provider. He is known in his community for his unconventional QA approach, making him an exceptional industry leader.
In this podcast episode, Yaron explains the fundamental role of the QA from his point of view - a service provider and not a slave of the regulations. He describes the benefit of this approach and how QA leaders can achieve that in their organizations.
The podcast is hosted by Yan Kugel and powered by Qualistery.
In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity.
Galit Lisaey is a Data Integrity consultant and Information Technology Project Manager, and Expert of 20 years.
Here are some of the points they touched during the discussion:
💡 Data life cycle and dot-connecting
💡 The human factor in data integrity
💡 Why people need to sit together and speak about risks
💡 How to use audit trail correctly
💡 How to set control points
💡 Why data integrity isn't mentioned in warning letters anymore.
Learn more about Qualistery at www.qualistery.com.
Watch the video episodes at podcast.qualistery.com.
GMP training is mandatory, but nobody explains how to conduct it correctly, effectively, or measure results.
Dominic Parry is the Director of Inspired Pharma, a company based in the UK specializing in GMP training. And in this podcast episode, he explains how to do all of the above and much more.
Here are some of the matters you will learn about in this episode:
💡 Presence vs. Virtual training
💡 How to improve virtual training
💡 How to keep people attentive in virtual training
💡 The advantages and disadvantages of external training
💡 Why it's vital to learn from other industries as well
💡 How to evaluate training effectiveness in pharma
💡 How to make the most of external training
💡 Staying ahead of what the regulators would like to see next
💡 How to design practical training
Watch the full video episode on podcast.qualistery.com
Learn about the GMP online training offered by Qualistery at www.qualistery.com
Davidek Herron is the Head of Global Digital Platforms & Operations at Teva Pharmaceuticals.
His mission in Teva is to leverage digital technologies to get medicines to patients in need in a more efficient, quick, and safe way.
In this podcast episode, Davidek talks to Yan Kugel about the importance of digital services for pharmaceutical companies and explains why their success depends on digitalization.
He also gives precious tips on how to achieve successful digitalization in any company.
Here are some of the topics you will hear about in this episode:
💡 Why people are the most critical part of digitalization
💡 How to forecast Out-of-Stock situations in pharma
💡 How to help doctors identify the right medicines for the patients
💡 Why Pharma Must Embrace Change and Digitalize
💡 Digital services on global scales
💡 How digitalization can help companies Withstand hardships like Covid-19
💡 Why pharma is behind other industries in terms of digitalization
💡 How to encourage change and progress across an organization
💡 What is the future of the pharma industry
You can watch the full episode on podcast.qualistery.com from 2020-12-21.
Learn more about us on www.qualistery.com
In this podcast episode, Vlatko Kantardjioski gives an amazing overview of equipment qualification in the pharmaceutical industry.
Vlatko is a Quality Assurance Specialist and served in leading positions in various equipment qualification projects.
Vlatko gives many expert tips and explains in details each stage in a pharmaceutical qualification:
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User Requirement Specifications
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Design Qualification (DQ)
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SAT (Site Acceptance Test)
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
Watch the full video episode on podcast.quaistery.com.
Learn more about our GMP courses on www.qualistery.com.
Do you know what cloud computing is and how to validate it for pharma use? You will know by the end of this episode.
More and more software become cloud-based, and pharma is not any different. Cloud computing holds in itself immense benefits but introduces new challenges in data integrity and validation.
Borislav Milev is a CSV expert specializing in cloud computing. In this episode, Borislav will make everything about cloud computing much clearer.
Here are some of the things you will learn about, listening to, or watching this episode:
- What Are Cloud Services and How to Validate Them
- How to Validate Cloud Services
- How to Work Agile in Pharma on CSV
- How to Choose the Right Clouse Service Provider
- What to Negotiate With Cloud Service Providers?
Watch the full video on podcast.qualistery.com
Risk management is a crucial part of the pharmaceutical quality management system. Unfortunately, many companies don't get it right and don't understand how to use ICH Q9 correctly.
In this podcast episode, Alex hall explains the right way to approach risk and which tools to use.
Here are some of the discussed topics:
💡 How to use ICH9 appropriately
💡 Tools to identify risks
💡 The first steps in any risk Management
💡 How to design your FMEA scoring system
💡 What is ALARP and how to use it in risk management?
💡 The Biggest Mistake People Do With FMEA
💡 What Are the Tools to Identify Risks?
Watch the video episode on podcast.qualistery.com
Master Risk Management in our live, virtual workshop- Quality Risk Management
Computer system validation (CSV) is more crucial now than ever. The reason for that is the digital transformation that pharma companies undergo in recent years. Additionally, with time, equipment, and software become obsolete. Thus, you need to replace it or update the software validated by the current GMP standards.
In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations.
Here are some of the topics you will learn about, listening or watching this podcast episode:
💡 The Stages of a Successful CSV
💡 How Is CSV Different From Other Process Validations
💡 How to Train People in CSV
💡 How to Use Screenshots Right for CSV
💡 The Biggest Misconceptions With Computer Systems
Watch the full video episode on podcast.qualistery.com
GMP Professionals have to deal with deviations daily, and one must admit that it is not the best part of the day. However, deviations are a crucial part of the QMS, and one has to deal with them with care.
Not doing so can get you in trouble with regulators very quickly. In this podcast episode, Yan Kugel interviewed Paul Palmer on how to deal successfully with deviations.
Here are some of the covered topics:
💡What Types of Deviations Are There?
💡What Is the Best Process to Deal With Deviations?
💡This Is the Worst Way to Retrain Personnel
💡Here Is Why It's Important to Update SOPs
💡What is the best way to approach deviations?
Watch the full video episode on podcast.qualistery.com
Learn how to handle deviations effectively by attending our virtual live Master Class: Managing Deviations From A to Z
In this episode of The Qualitalks Podcast, Yan Kugel interviewed Thomas McMann about the role of Contractors & Consultants in the pharmaceutical industry.
Working in a permanent job has its benefits, but also being an independent contractor or consultant. This work can be fantastic for many people who work in the pharmaceutical industry, but want a change in pace or just had enough of organizational politics.
Thomas is head of contacts at EPM Scientific Switzerland, and during the podcast, he addresses the following topics:
Here are some of the things Thomas told me about:
💡 Who should consider becoming an independent consultant
💡 What are the advantages and challenges of independence?
💡 What roles are there for pharma quality experts
💡 How many years of experience do you need in pharma before you can become an independent consultant?
💡 Why CSV is such a hot topic right now
💡 How to start-up your consultancy career
💡 How to find the best contracts
💡 What can you expect to earn
In this episode of The Qualitalks Podcast, Yan Kugel talked to Dr. Rhett Pascual, Ken Toley, and Dr. David Guy Brizan. They are the team responsible for CALIDAD AI, a company changing how GMP inspectors will conduct their audits.
Here are some of the things that you will learn about in the podcast:
💡 Why Auditors Need Electronic Help
💡 Why It Is the Right Time for Pharma to Digitize
💡 How AI Can Help You During an Audit
💡 What Really Stops Pharma From Digitalizing?
💡 The Cost of Not Spending on Quality Is High
Watch the full video episode on podcast.qualistery.com
Quality indeed means doing it right when no one is looking. However, preparing well for a regulatory audit is a vital task. A good preparation may turn the tides around and save you from critical findings.
In this episode, I've interviewed Paul Palmer on how to prepare correctly for a regulatory audit. Paul has been in the Pharmaceutical industry since 1986. He is a QP, a consultant, and a business advisor.
Here are some of the things, that you will learn about in the podcast:
💡 The Benefits of Preparing Well for an Audit
💡 Who Is Fit to Speak During an Audit?
💡 Tips on How to Use Gap Analysis for an Audit Preparation
💡 The Roles of the Audit Support Squad
💡 How to Prepare Your Warehouses for an Inspection
💡 Why Even the Finance Department Should Know GMP
💡 How to Choose and Prepare Subject Matter Experts When You Are Audited
Watch the video episode on podcast.qualistery.com
At Qualistery, we love talking to innovators within the pharmaceutical world. In this episode, Yan Kugel interviewed Florian Hildebrand and Carla Peraferrer.
Florian is the CEO, and Carla is the Head of Quality at Qualifyze (Formally ChemSquare), a start-up that wants to change the way you conduct audits and qualify your suppliers. They provide auditing services across the world and believe that the future of supplier qualification lies within shared collective knowledge.
Here are some of the discussed topics:
💡 Who are Qualifyze and what is their mission?
💡 Why companies should share their audit reports globally
💡 What does qualification by the collective mean?
💡 How to adapt technologically to the pandemic reality
💡 How to conduct a successful virtual audit
You can watch the full video episode on
podcast.qualistery.com or YouTube
Data integrity is a big deal nowadays, and many companies get warning letters due to non-conformities in this area.
In this podcast, Daniel Milek, a Data Integrity expert, explains what data integrity is and how to maintain it correctly.
Here are some of the discussed topics:
💡Why Data Integrity Is More Important Now Than Ever
💡What Is the Definition of Data Integrity?
💡What Are the Main Causes of Data Integrity Non-Compliance?
💡Who Are the Best People to Validate a Software?
💡What Are the Departments That Are Impacted the Most From Non-Compliance?
💡How to Write Good User Requirements Specifications
You can watch the video podcast here.
Yogesh Krishan Davé has been working in the pharmaceutical industry for more than 40 years now.
He is an EU Qualified Person and a consultant. During this long time, Yogesh has encountered many deficiencies from which most pharma companies suffer.
In this podcast, Yogesh has addressed deficiencies in two systems and explained how to tackle them:
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Training
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Deviations and CAPA handling
Here are some of the things that you will learn about in the podcast:
💡 Training - One of the Biggest Deficiencies in the Pharma Industry
💡 How to Motivate People Outside of QA to Be Part of the Organizational Compliance
💡 Why The pharmaceutical industry should stop being arrogant
💡 How to Stop Chasing CAPAs and Wasting Men Hours
💡 How to Stop Losing Precious Time on Petty Deviations
You can watch the video episode on podcast.qualistery.com.
Learn how to write efficient standard operation procedures (SOP) at our live virtual workshop - Writing Standard Operating Procedures (SOPs)
During his work in various pharmaceutical industry roles, Ammar Badwy has understood how difficult it is to find suppliers of raw materials that meet all the requirements. Therefore, Ammar has founded Pharmaoffer, a virtual marketplace that allows pharma companies to find qualified suppliers quickly and easily.
Here are some of the things, you will learn about in the podcast:
💡What is Pharmaoffer, and What Do They Offer?
💡Ammar's Journey from Cleanroom Repackaging to CEO
💡Why Finding New Qualified Suppliers Doesn't Have to Be Hard
💡The Future of the Digital Pharma Industry
💡Applications in Pharma Must Don't Have to Be So Complicated
In this episode of the Qualitalks Podcast, Alex Halland Yan Kugel discussed Risk Management in the pharmaceutical industry.
Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, which can cause them a lot of money and risk customer lives. Any decision–making process about risks to product quality involves risk management to a greater or lesser extent.
Here are some of the things that we can learn in the pharma industry about Risk Management:
1. What is the definition of Risk?
2. How does it affect the pharma industry?
3. How to avoid these Risks in the pharma industry?
4. What is the Role of Upper Management?
5. What are the strategies for Risk Management?
Watch the video episode on podcast.qualistery.com
Master Risk Management in our live, virtual workshop- Quality Risk Management
Digital transformation is the future of the pharmaceutical industry. Having an electronic quality management system (eQMS) in place means better efficiency, convenience, and compliance. However, the transformation is not a simple thing as it is a critical change for the quality system.
So why should you go through it and how to do it correctly?
In this episode, my guest is Doron Sitbon, the CEO of Dot Compliance, a company that provides an eQMS solution for pharma, and he is going to answer those questions and much more.
Here are some of the topics we have discussed:
💡 Why companies should commit to digital transformation
💡 The challenges and the benefits of a digital transformation
💡 What types of eQMS are there and how to choose the right one for you
💡 How to successfully implement an eQMS in your company
The pharmaceutical industry is very lucrative and offers many employment possibilities. However, finding the right position for starting or advancing your career may present itself as challenging.
To help you with your job, Matthew Lancaster shares valuables information that will help you navigate this challenging industry and maximize your career achievements.
Matthew is the Director of Quality & Regulatory recruitment at Life Science People.
Here are some of the topics Matthew Lancaster and Yan Kugel discussed in this episode:
💡What is the main reason people fail at job interviews
💡Which are the hottest position in the industry
💡What to do if you didn't get the job you wanted
💡Where in Europe it is easier to find your first job in pharma
💡Why you SHOULD become a Qualified Person (QP)
💡Should you, or should you not stay in one company for many years
In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.
Jennifer talks and gives practical advice on how to perform a successful supplier or internal audit from start to finish.
Here are some of the topics we covered in our talk:
💡01 Secrets to a Successful Audit Opening Meeting
💡02 Here Is When Repeated Deviations Are Acceptable
💡03 Why Time Good Time Management Skill Is Important for Auditors
💡04 Here Are the Most Common Mistakes That Companies Do-
💡05 Here Is an Important Message for Auditees-
💡06 How to Write a Good and Useful Audit Report
💡07 This Is Why Audit Trends Are Important-
💡08 How to Become a GxP Auditor
💡09 Here Are the 3 Qualities of a Good Auditor
Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.
In this episode of the Qualitalks Podcast, our guest is Jennifer Kussauer, a senior international GxP auditor.
Here are some of the topics we covered in our talk:
✅The Art Behind Being a Great Auditor
✅The Biggest Challenges of an Auditor
✅Why Companies Should Be Here Is Why Companies Should Be Happy to Be Audited
✅The Best Thing About Auditing
✅Why the Opening Is So Important for a Successful Audit
✅Knowing the Scope Is the Foundation of the Audit
✅The Most Common Mistakes of Audit Preparations-
✅Expert Tips for Junior Auditors on How to Learn Their Standards
Jennifer served as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant with expertise in GCP/GVP/GMP/GDP.
The manufacturing of sterile drugs is a critical and essential process. For the process to conform to the strict GMP requirement, it is crucial to design every aspect of the manufacturing with high quality in mind.
In this episode, Ashwani Tripath, head of compliance at Alembic Pharmaceuticals, explains what’s important to take into consideration when designing new aseptic manufacturing.
Here are some of the things you will learn from watching or listening to the episode:
- How to design a cleanroom
- Risk assessment for newly designed cleanrooms
- How to deal with unexpected deviations in a project
- What to keep in mind when you choose cleanroom equipment
- What Is the Most Complicated Equipment to Qualify
- What is the most complicated equipment to qualify
- How to avoid contamination by personnel
Working in the pharmaceutical industry has its perk, as there are countless opportunities for career advancement. However, finding the right opportunities in the vast GMP world can be challenging. Therefore, having the right headhunter on your side can be highly advantageous.
Yet, not every headhunter is an excellent recruitment consultant. Dealing with the bad weeds can waste you a lot of time, leading to nothing, but dealing with a good one, can land you the gig of your dreams.
Matthew Lancaster is Head of Quality & Regulatory Pharma recruitment at EPM scientific. And in this podcast episode, he is going to explain to us:
02:35 - What Is the Role of a Good Headhunter in Pharma
13:41 - How Collaboration With Good Headhunters Can Benefit You
18:51 - Why Recruiters Should Be More Transparent and Honest
26:10 - How to Recognize a Serious Headhunter
40:13 - What Are the Hottest Positions in the Pharma Right Now
42:27 - What Impact Did the Coronavirus Have on the Recruitment
You can watch the full video here
Building a successful career in pharma is complicated and requires specific tools, knowledge, and traits. But you can do it with any educational background if you have a healthy hunger for knowledge.
Jennifer Kussauer studied communication. Nonetheless, she built a fantastic pharma career and functioned as an Associate Director, Head of Audits and Inspections Management at Merck KGaA, Darmstadt, Germany. Now she is an independent QA/QM Consultant.
In this podcast episode shares how she managed to build a great career without scientific education. We also dive into the fascinating world of GXP audits.
The full video of our talk will be available from Monday 08.06.2020 on www.qualistery.com.
Today, most experienced pharmaceutical professionals want to become quality auditors, but they are not guided well or not having that much information about how to do it.
By listening to this podcast, featuring Shoab Malek, you will have a clear idea about the role of GMP Auditor, how to become a one, the challenges, tips, and much more.
Shoab Malek is an experienced & professional Pharmaceutical Consultant and GMP Auditor. He has faced many regulatory audits, which include USFDA, EU-GMP, PICs, UL Registrar LLC (USA), and 100+ vendor audits across India, China & Egypt.
China is the most crucial supplier of chemicals to the pharmaceutical industry because it is not easy to find the alternatives that they have to offer. But there is a lot to consider when sourcing from China. But you have to do a lot of homework.
Oliver Rhode is the CEO of XENOPS Chemicals and an expert on raw material sourcing from China for the pharma industry. In this episode, he shares his secrets to success in finding the right suppliers in China.
Watch the video on qualistery.com
Proper time management is essential for every worker in the pharmaceutical industry because many of the processes have strict deadlines. Not finishing tasks on time may lead to non-compliance.
In this episode, Yan Kugel talked to Paul Palmer about time management tools and methods, which can help people complete their tasks much more efficiently and promptly.
Watch the video on www.qualistery.com from May 18th.
In this episode, Yan Kugel talked to Dr. Michael Drues about medicinal combination products.
Michael is an internationally recognized expert and featured keynote speaker on cutting edge medical technologies and regulatory affairs.
Listening to the podcast and reading the article, you will learn:
- What is a combination product?
- What are some examples of combination products?
- What are the roles of the Office of Combination Products?
- How are combination products assigned for review?
- What types of marketing applications are required for a combination product?
- How are adverse events reported for combination products?
- A Three-Step Path toward Combination Product Approval
- Challenges with Combination Products
Watch the video talk on Qualistery.com
Due to the COVID-19 situation, governments across the world initiated lockdown and quarantines. The lockdowns have a severe impact on pharmaceutical manufacturing across the globe. Some of that include:
- Shortage of raw materials
- Personnel deficiency
- Export bans
- Severe financial damage
All those obstacles lead to a unique manufacturing environment, which may lead to quality deficiencies.
During their talk, Hitendrakumar Shah, the CEO of NADH+ GXP Compliance Services, shared with Yan Kugel his suggestions on how to avoid quality issues during manufacturing, throughout that particular time.
You can watch the podcast in a video format on www.qualistery.com
In this episode, Yan Kugel talks to José Sergio Ávila, a validation, and sterilization specialist, about validation activities in the pharmaceutical and medical devices industries.
We covered several topics with Sergio:
- EtO sterilization
- Importance of purified water systems and validation challenges
- Validation of medical devices and the differences to pharmaceutical validation
- How to stay current with the new regulation in the quickly developing field of validation
- Biggest mistakes people do when they perform validations
- The Key for successful validations
- Tips for becoming experts in the field
Watch the video and read the article- here.
Shoab Malek is a pharmaceutical consultant and a GMP auditor, located in India. He talked to Yan Kugel about the big challenges that India faces because of COVID-19. Being the biggest generic pharmaceutical exporter in the world, it may influence the whole world. The prices in India for many drugs have already doubled or tripled, for many reasons:
- Raw material shortage
- Packaging material shortage
- Shortage of skilled workers
- Not enough storage places for finished goods
- The supply chain to the rest of the world has completely stopped
The videocast is available on
www.qualistery.com
In this episode of the Qualitalks Podcast, Alex Hall and I discuss the most crucial role of the Qualified Person in the pharmaceutical industry.
Listening to the podcats and reading the article, you will learn:
- About the role of the Qualified Person (QP) in the European Union
- The difference between a QP and a quality manager
- Who should consider becoming a QP
- The legal requirements for becoming a QP
- What soft skills are required to become a QP
- Tips for success in becoming a QP
Watch the video:
www.qualistery.com
Paul Palmer and I talked about the quality assurance (QA) and Quality Control (QC) philosophy in organizations. Many companies don't get it right, and it costs them in compliance, time, and money. But it is not too late for any company to change that.
In the podcast/article, you will learn: * What QA philosophy is * What benefits QA philosophy holds * How to implement the QA Philosophy across the organization * What mistakes to avoid when looking at trend analysis * Why and how to choose consultants to support you
The pharmaceutical industry is a fascinating and complex field. Countless people work hard to release a quality product to the market. In the Qualitalks podcast, we talk to experts, leaders, and innovators who tell us how they do it! We talk about GMP, business, quality, and everyday life in the pharmaceutical industry.