Episódios
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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This podcast from Rachel Carmichael explores the expectations from the diverse guidance documents and give practical suggestions on addressing your needs.
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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’.
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We believe remediation following a tough inspection is an opportunity to emerge stronger and more confident. Find out how by applying our 3Cs approach.
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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.
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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.
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Reviews and compares the 2011 FDA Guidance and the recently published EU CHMP and draft GMP Annex 15 requirements for Process Validation.
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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.
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