In Part 1 of this webinar series, we will discuss the implications of current regulatory trends and how this impacts the expectations for bacterial retention testing (BRT) studies. We will also address the challenges of applying critical process parameters (CPP) to the design of a bacterial retention study, as a part of the aseptic filtration validation process. The recent regulatory observations will be discussed as cases.
In this webinar, you will learn:
- How BRT fits into the validation strategy for aseptic filters
- About current regulatory trends and expectations for BRT
- How to best incorporate CPP for various drug delivery systems
The 2nd webinar in this series, Case Studies: How to Incorporate Critical Process Parameter (CPP), is also available.
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.
Ramesh Raju
Merck
Head of Operations BioReliance® Validation Services Lab
Ramesh is currently the head of operations, BioReliance® Validation Services lab of Merck at Bangalore which provides aseptic filter validation services to Asia & Oceana, Middle East, Africa, LATAM, and Mexico along with the Indian subcontinent. Previously, he was managing the technology management team in India at Merck. Ramesh has more than 20 years of experience in aseptic processing and validation of injectables. He is currently pursuing his doctorate program in extractable and leachable from Kuvempu University.
Pharma and biopharma manufacturing
- Sterile Filtration Strategies
Duration:49min
Language:English
Session 1:presented October 5, 2021
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