Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholders from selected industry organizations. The current Annex 1 draft emphasizes Contamination Control Strategy (CCS) multiple times and as a key consideration.
In this webinar, you will learn:
- Closed Processing and Single-Use Technology implementation
- Points to consider using Single-Use Technology
- Sterile Filtration
Speakers
Somasundaram G (Som)
Merck
Senior Consultant
Som is a consultant with customers for regulatory compliance, closed processing, and other areas in biopharmaceutical applications. He is also a member of PDA and ISPE industry associations. Som has worked in different functions within Merck for the last 19 years, including heading technology management, tech service, BioReliance® filter validation lab, commercial role, and business development areas. He also worked for a year in QA/QC as well as obtained one year of academic experience in microbiology.
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant
Simone Biel provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on single-use technology. Over the years, Simone has supported biopharmaceutical drug manufacturers’ implementation of single-use technology in their manufacturing process. With her deep understanding of single-use technology market needs and industry trends, she is the subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in microbiology.
Pharma and biopharma manufacturing
- Sterile Filtration Strategies
Duration:56min
Language:English
Session 1:presented June 8, 2021
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