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.