Sterile Filtration in the Annex 1 Era: Interpreting PDA TR 26 (Revised 2025)
Webinar
Key updates in PDA TR 26 (Revised 2025) and their practical implications:
- How the industry is shifting from compliance-based validation to risk-based sterility assurance
- The role of PUPSIT and integrity testing in closing critical sterility gaps
- Understanding risk window and flaw masking in filtration systems
- Practical approaches to meeting Annex 1 expectations with confidence
Speakers
Partha Banerjee
Merck
Technical Application Expert, Downstream India
Partha brings over 17 years of extensive experience in downstream bioprocessing. He specializes in biopharmaceutical process development, with deep expertise in sterile filtration, filter optimization, and troubleshooting complex manufacturing challenges.
Aria Kang
Merck
Regional Strategy Execution Manager - Downstream Process
Aria has diverse background in the broader pharmaceutical, clinical research, and life sciences industries that commenced with a degree in Biotechnology over a decade ago, her passion is to understand the needs and drivers of the market and deliver applicable Downstream solutions to customers.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:1h
Language:English
Session 1:Tue, August 4, 2026 2:00 PM SGT