Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date The Role of the Pre-use Post-sterilization Integrity Test (PUPSIT)... Mihir Kumar Patel at Cytiva, and Sasha Nikolić at Reig Jofre Full title: The role of the pre-use post-sterilization integrity test (PUPSIT) in a contamination control strategy. The recent revision of EU GMP Ann... November 1, 2023 2:00pm Implementation of a Fully Automated & Integrated Continuous Biomanufacturing Irina Ramos at AstraZeneca and Britta Anderson at Merck Development and Implementation of a Fully Automated and Integrated System to Enable Continuous Biomanufacturing for Clinical Scale There are many exc... 3 weeks ago | 100 mins Quality and Compliance Requirements For Cell and Gene Therapy Products Sanjay Pandey, CAR-T, QA & Regulatory lead, Immuneel Therapeutics This presentation will outline Quality and Compliance Requirements For Cell and Gene Therapy Products which incudes”: - Facility compliance - GMP qu... November 24, 2023 8:30am GMP Implementation of Continuous Manufacturing: A case study Neil Soice at Amgen, Inc. and Michael Phillips at Merck Continuous processing is being explored in various ways throughout the biopharmaceutical industry. New process technologies and business consideratio... 6 months ago | 89 mins The Use of AI and ML in Pharmaceutical Manufacturing... Dr. Gert Thurau, Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Roche Full title: The use of AI and ML in pharmaceutical manufacturing - the evolving regulatory environment in the GMP and CMC Reg space in the US and Euro... January 17, 2024 2:30pm PMI Trustee Workbench - Panel Discussion: GMP Equalisation Conversion Bill Tim Middleton, Sonya Fraser, Mark Williams & Judith Fish On 28 April, the Pension Schemes (Conversion of Guaranteed Minimum Pensions) Act 2022 was given Royal Assent. Margaret Ferrier’s Private Member’s Bill... 12 months ago | 39 mins PMI/SPP Scotland regional group: Wellbeing/Covid & Latest on GMP Equalisation John Wilson, Spence and Partners Wellbeing & Covid: David Collington and Laura Matthews, Barnett-Waddingham Latest on GMP equalisation – HMRC and PASA guidance, and third Lloyds Bank... 3 years ago | 67 mins Integrity Assurance for Single-Use Systems: End-User Perspective Charlotte Masy at GSK Vaccines and Patrick Evrard at Pall Life Sciences Single-use technologies are more and more used in critical sterile applications, e.g. close to final manufacturing steps handling Drug Product, leadin... 2 years ago | 126 mins GMP equalisation – The role of the administrators Lucy Cresswell | Barnett Waddnigham, Tim Smith | Herbert Smith Freehills - Designing the equalisation solution, looking at PASA's guide to methodology - Decision points and other variables - Legal and tax challenges - Wit... 3 years ago | 48 mins New-Drug Development: Succeeding With the FDA Premier Research Moving an investigational new drug through FDA approval can seem like a monumental task. It’s a complex and demanding journey, but understanding the s... 10 months ago | 43 mins Load more