NSF Health Sciences: Recent Episodes
NSF pharmaceutical and medical devices team
Access a wealth of free podcasts and webinar recordings from our pharmaceutical and medical devices experts that will help you make better business decisions as well as to stay up to date with the latest industry trends.
Listen to Martin Lush and Global Quality leader Anders Vinther as they discuss COVID-19 and the "return to normal" as offices open back up globally.
Rizwan Chaudhrey interviews NSF expert Martin Lush on the current climate in the pharma industry.
Rizwan Chaudhrey, Founder and CEO of RSK-Solutions, sits down with NSF expert John Johnson to discuss drug shortages, the factors causing them and what regulators can do to help.
NSF’s John Johnson sits down with Paul Merrick, a Chartered Mechanical Engineer with over 30 years’ industry experience, to discuss GMPs associated with engineering services during a crisis or prolonged shutdown. Paul shares key advice on how to reopen facilities after a shutdown, the key advantages and disadvantages to outsourcing, and QA’s role when it comes to outsourced engineering certificates.
In this podcast, John Johnson discusses the product disposition process including batch review, rejection and the importance of EudraLex Volume 4. He shares stories from his experience in industry and provides key take-home messages for those involved in the process.
In this podcast, expert John Johnson gives his top tips for communicating clearly and effectively during unprecedented and unpredictable times.
Podcast. Martin Lush interviews pharma professional Anders Vinther about his 30 years in industry, including some of his greatest career challenges and how he overcame them.
NSF/ANSI 455 defines the audit process and certification body requirements for OTC drugs’ GMP compliance. In this podcast, Jim Morris describes the standard development process, key stakeholders, structure and key elements of the NSF/ANSI 455 standard.
In this podcast, David Waddington looks at the most common European and U.S. FDA regulatory findings related to basic cleaning issues including cross contamination and approaches to cleaning validation.
To gain Qualified Person (QP) status in the UK, candidates must apply to one of three professional bodies (the Royal Society of Biology, the Royal Society of Chemistry or the Royal Pharmaceutical Society). This podcast explains the process and provides guidance to both potential candidates and their employers on how to succeed in gaining eligibility.
For too long in the pharma industry, those at the sharp end have been blamed for most deviations and unplanned quality incidents. Why? Because it’s quick and convenient. In this podcast, Martin Lush shares his advice on how to improve your SOPs and reduce human error.
This podcast includes essential facts about habits and why any change creates a risk of 'error'. It includes some hints for success when it comes to changing your habits in the workplace.
This podcast from Rachel Carmichael explores the expectations from the diverse guidance documents and give practical suggestions on addressing your needs.
This podcast explores the key areas that regulators would expect to be under control at your pharmaceutical operations. These include cross-contamination control, facility layout, material/people flows, premises and equipment cleanliness, change control and documentation.
In this podcast, John Johnson summarizes how the world’s leading pharma companies are using a variety of tools and techniques to measure and reduce the ‘Cost of Poor Quality’.
We believe remediation following a tough inspection is an opportunity to emerge stronger and more confident. Find out how by applying our 3Cs approach.
In this short podcast, John Johnson gives a summary on the proposed changes to EudraLex Volume 4, Annex 1. John gives his insight into the key parts of the update and how these may affect you, as well as providing some interpretation on how the changes may be inspected or enforced by the regulatory bodies.
Excipient GMP certification is becoming an expectation of pharmaceutical excipient customers. Catch up on this podcast from NSF's expert Jim Morris. Jim describes key elements of the standard, which areas are often cited as weaknesses and strategies for conducting an effective GMP gap assessment of an excipient manufacturer.
Reviews and compares the 2011 FDA Guidance and the recently published EU CHMP and draft GMP Annex 15 requirements for Process Validation.
Created in collaboration with the Indian Drug Manufacturers’ Association, this unique, internationally recognized and independently assessed program has been specifically designed for Indian companies who want to succeed in U.S. and European markets, providing you and your company with what it needs to succeed. Find out more about our advanced PQM program.
This podcast covers the trends and priorities when assuring data integrity from the perspectives of the U.S. FDA, MHRA and other regulatory bodies.
This podcast from Martin Lush highlights the vital importance of thinking differently and becoming a disruptive and critical thinker. How do you ask bigger and better questions that take your departments and areas into better directions? Listen to the podcast to find out.
This podcast focuses on the critical prevention of errors, providing the 10 best practices to prevent errors and how to implement them in order to fix a culture of blame manufactured by a broken system.
Look at many Warning Letters and Consent Decrees and you will see one observation often sticks out. The failure to identify root cause leading to high levels of repeat deviations.
This podcast explores aspects of GCP and PV relevant to QPs and quality professionals. We cover what is different when releasing IMPs, what to be aware of beyond GMP, how to ensure product technical complaints link with safety reporting and examples of what can go wrong.
This podcast by Martin Lush focuses on the psychology of human error – why do intelligent and committed people make mistakes? Martin also details best-in-class practices in terms of preventing human error.
In this podcast, Martin Lush draws on his wealth of experience to explain how to approach making controlled and justifiable decisions when under pressure and short of time.
In this short podcast, Catherine Kay details the role of the QP, including what skills and qualities a QP should demonstrate, why QPs are important in your organization and how they can add value.
This podcast introduces the CAPA hierarchy which we developed based on an analysis of FDA warning letters. This simple tool helps investigators identify more robust and effective corrective and preventative actions. Most of us tend to retrain or write additional complexity into plant SOPs. Our CAPA hierarchy pushes investigators to apply a structured approach to identify CAPAs that truly address root cause(s).
Traditional training doesn’t stick, but education does. In this podcast, Martin Lush presents a case study on the 10/20/70 model, illustrating how it works and providing you with practical training tools and techniques that you can use immediately in the workplace.
This podcast will provide you with the tools and techniques to drive out complexity and wet your appetite to win the war against this silent enemy.
In this podcast, John Johnson details the importance of having a proactive approach to quality risk management. John covers what ICH Q9 requires you to do, why staff behavior is crucial in maintaining a proactive approach to the quality risk management process and three common tools: policy development, failure mode and effects analysis, and contamination control strategy.
Every warning letter or equivalent is preventable. We believe it’s better to spend $100,000 preventing such action than millions in painful remediation. Listen to this podcast for invaluable guidance.
NSF International's expert Martin Lush gives his insight into the political landscape and the future of the pharmaceutical industry in the 30 minute podcast.
While humans are prone to error we often face huge obstacles to getting things done in the work place. This podcast focusses on strategies highly effective work units employ to maximize reliability and minimize human error. The podcast provides ideas of things you can do as supervisor, manager or individual contributor to maximize your unit’s performance.
Microbial contamination of products and processes is one of the biggest causes of product recalls and severe regulatory actions. This podcast will give you a good understanding of the sources and routes of microbial contamination and practical guidance on prevention.
In this podcast, John Johnson details the secret to fewer repeat problems and how to stop making the same mistakes. John explains how you can error proof an operation to provide enhanced product quality assurance, reduced cost and improved GMP compliance.
The root cause of genuine data integrity problems is culture, not simple errors in lab records. If you want to understand and fix the behavioral causes, listen to this podcast.
Learn how to use data from your auditing process to drive continuous improvement, including the key skills and methods used by the best performing companies and how they might benefit you. This podcast also includes an NSF case study.
Get an update on key developments and how they may affect your pharmaceutical business.
Mike Halliday focuses on best industry practices for auditing and self-inspections. Learn how you can make your self-inspection program world-class!
How well your company manages change will have a massive impact on your future. Find out how to ensure a fast and effective change control system in this podcast.
This podcast demonstrates how to maximize efficiency by reducing human error and consequently improving reliability.
Martin Lush, Global Vice President of NSF Health Sciences, gives his insights on how companies can go about changing GMP behaviors and in doing so change quality culture.
This podcast covers how the best companies respond in a crisis, using systematic approaches to make the right judgement. Specifically, we focus on understanding the extent of the quality defect, bringing together a strong cross-functional and acting in a timely manner. We also consider the effectiveness of different types of CAPA – particularly why the obvious trio of “discipline, training and procedures” is not good enough.
So many companies waste money on training that has no impact. The learning stays in the classroom and is forgotten in the workplace, where it really matters.
Did you know that inadequate investigations are the most often cited issue in FDA warning letters? This podcast from expert Andy Barnett addresses the most frequent investigation gaps cited by the FDA and provides a framework for improving investigation reports.
Learn from the latest research on decision making how to use a simple, structured approach that keeps the emotion, stress and bias under control.
Learn how to do more with less. This podcast from John Johnson will help you allocate the resources of your role and your team. It includes links to ICH Q9 Quality Risk Management, effective communication strategies and long-term compliance to cGMP. It also covers how human behaviour drives success.
We asked 100 seasoned pharma professionals to share their tips on how to succeed and stay sane. Listen to this podcast to benefit from 1,000s of years of combined experience.
This podcast presented by NSF's expert John Johnson covers why Annex 1 is being updated and what the updates are expected to achieve. He also takes a deep dive into how you can generate a contamination control strategy in your sterile production unit to help you identify and mitigate risk, and improve product quality.
Lynne Byers explores different models for managing both internal company teams across a global organization and third-party contract manufacturers.
How do you design a risk-based and cost-effective validation program to meet cGMP expectations? This podcast provides an overview of the new science and risk-based approach to validation that is now enshrined in guidance from both the U.S. FDA and the EU.
By the end of this podcast by NSF's Pete Gough, you will understand what regulatory affairs includes and how this impacts the role of the QP and QA.
Is your life consumed by KPIs? Want to know how to generate measure that work for you, not the other way around? We believe less is more. If you’re suffering from death by measure this could save your life.
This podcast offers perspective on pharmaceutical quality systems 10 years after the issuance of ICH Q10 and describes the most common quality system weaknesses, ways you can assess your quality system and management’s commitment, and opportunities to consider to unlock the value of the quality management system.
How do the best companies remain inspection ready by design rather than good fortune? In this podcast, John Johnson covers what perpetual GMP compliance means and details how you and your organization can achieve it. He also introduces the basic toolkit used for inspection preparation.
There is risk in everything we do. The key to our success is how we manage it. This podcast will show you how best-in-class companies gain significant commercial and regulatory advantage by managing risk intelligently.
This podcast from expert Rachel Carmichael provides an introduction to ISPE's Cultural Excellence report. NSF views the culture of an organization as what your people will do when no one is looking. We cover how you can set steps in place to measure and improve your quality culture, and keep it refreshed.
In this unpredictable world, companies who can take the hits from unplanned events and bounce back stronger will prosper. Want to know how to become more resilient? Listen to this podcast.
Most QA and technical mid-level staff are surrounded by people in similar positions and assume that key decision makers think the same way and talk the same language. They don’t. This podcast will explain how those with a technical, operational and QA background should communicate with business leaders to get things done.
More of us are turning to outsourcing, which is a major strategic decision that shouldn’t be taken lightly. There are many steps in establishing and nurturing a relationship with an external partner, involving both technical capability and personality fit, but if done right it pays off for both you and your partner. Listen to this podcast to learn more about using outsourcing to advance your operation.
In this podcast, John Johnson details the importance of having a proactive approach to quality risk management. John covers what ICH Q9 requires you to do, why staff behavior is crucial in maintaining a proactive approach to the quality risk management process and three common tools: policy development, failure mode and effects analysis, and contamination control strategy.
This white paper podcast by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating GMP deviations or deficiencies in sterile processing.
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.
Over the last 27 years, NSF Health Sciences has observed how common sense is not always translated into common practice. In this white paper podcast, Martin Lush talks about some key reasons why intelligent people do strange, irrational things in respected organizations.
Strategic well-planned remediation is paramount to long-term sustainable corrections and corrective actions. In this white paper podcast by NSF International’s Maxine Fritz, the value of a systems approach to corrective actions is discussed, highlighting the importance of the three “Cs to success”.
In this podcast, NSF International’s Andy Barnett shares his personal experiences about quality costs, and presents strategies on how to estimate quality costs. Often, he says, these efforts at estimating the cost of quality—and acting on them—are well worth the investment of time.
This podcast includes 'Five to Fix’ quick tips that will help you create error-free SOPs. SOPs that ensure consistency, not confusion. It also includes an example client NSF worked with who were having trouble with their SOPs.
This podcast, Martin Lush addresses the current complexity crisis in the pharma industry. He explains the costs of over-complexity, the true root causes and details how your company can move from complex to simple.
This white paper podcast provides an overview of some of the different types of and concerns regarding data integrity. The scope of “data integrity” in this white paper is limited to pharmaceutical quality control laboratories.
Pharma regulators are getting increasingly frustrated by repeat errors and the focus on the person, not the system. We tell you what you can do.
This white paper podcast describes what drives human behavior at the simplest level. It also identifies five steps that can help organizations successfully change GMP behaviors.