PDA and BioPhorum have partnered to form a task force whose goal was to provide the industry and regulators with scientific data and analysis on the potential risks and benefits of implementing PUPSIT to improve sterility assurance. This webinar will describe the data generated by the task force studies and discuss considerations and best practices when implementing PUPSIT.
In this webinar, you will learn:
- How changing industry perspectives help overcome regulatory concerns and may influence regulatory perspective
- How improved process understanding affects risk assessment
- How improved final fill assembly design simplifies PUPSIT
Speakers
Janmeet Anant, Ph.D.
Merck
Senior Regulatory Consultant
Janmeet Anant is a senior regulatory consultant, focused on biopharmaceutical manufacturing at Merck. Janmeet serves as an executive board member for the Bioprocess Systems Alliance (BPSA) and a member of the Regulatory Governance Team at BioPhorum.
He has more than 20 years of experience, moving through technical application roles for chromatography, filtration, cell culture and, most recently, regulatory consulting. Janmeet has a B.S. in Chemistry and a Ph.D. in Pharmacology.
Andrew Koch
Merck
Technology Manager, Sterile Filtration
Andrew Koch is a customer applications specialist at Merck, supporting bioprocessing customers in sterile filtration with a focus on single-use redundant filtration and pre-use post-sterilization integrity testing. He has presented at several conferences and workshops on single-use final filtration assembly design. Andrew has a B.S. in medical biology from the University of New England and an MBA from Southern New Hampshire University.
Pharma and biopharma manufacturing
- Sterile Filtration Strategies
Duration:45min
Language:English
Session 1:presented March 18, 2021
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