How PDA TR 26 (2025) & ASTM E3469-26 influence your sterilizing-grade filter validation
Webinar
The biomanufacturing industry relies on regulatory guidelines, recommendations outlined in PDA Technical Report 26, and the ASTM E3469-26 standard, to guide sterilizing filtration operations and validation. In this webinar, we will explore how these documents are shaping filter validation strategies.
In this webinar, you will learn:
- Updates to PDA TR 26 & new ASTM E3469-26
- How to design bacterial retention studies for your filter
- How to incorporate process-specific filtration parameters into the validation study design
Speakers
Annie Leahy
Merck
Senior MSAT Manager
Annie Leahy is a Senior Manufacturing Sciences and Technology (MSAT) manager, leading a highly technical team that ensures successful implementation and ongoing operation of customer applications across the manufacturing process in the areas of clarification, virus filtration, TFF and aseptic processing. For more than 18 years Annie has specialized in virus filtration, sterilizing filtration and integrity testing. She was one of the authors of the 2025 revised PDA TR26. Annie holds a master’s degree in biotechnology.
Pascale Richert
Merck
Senior Validation Services Consultant
Pascale Richert is a Senior Validation Services consultant and provides regulatory & validation expertise to our customers with a focus on sterilizing filtration systems validation. For more than 20 years Pascale has helped biopharmaceutical drug manufacturers to demonstrate that their filtration systems used in drug production contribute to safe drug manufacturing. Pascale holds a Master Degree in Biochemistry & microbiology.
Pharma and biopharma manufacturing
- Downstream Processing
Duration:1h
Language:English
Session 1:Thu, October 29, 2026 3:00 PM CEST