On Demand Webinars
Assessing the Use of Solid-Phase Cytometry for Rapid Bioburden Testing
Presented by Sophie Drinkwater, Associate Director in Microbiology at AstraZeneca
01st September 2025
Read Across Assessment for Potential Leachables Without Toxicological Data
Presented by Yana Chervona, Associate Research Fellow at Pfizer and Patricia Parris, Global Risk Assessment Services Toxicologist at Pfizer
13th August 2025
Quality by Design: Enhancing Biopharma Validation and Microbial Retention Assurance in Sterilizing Filters
Presented by Gregory S. Blank, Ph.D. Independent Consultant and retired Director, Late Stage Purification Department at Roche Genentech, Annie Leahy, Senior MSAT Manager at MilliporeSigma, Jennifer Juneau, Senior Principal Scientist at Pfizer,
11th June 2025
Charting the Universe of Organic Extractables
Presented by Dennis Jenke, Principal Consultant of Nelson Labs EU
12th May 2025
Beyond USP <86>: Supplemental Testing
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates, John Duguid, Executive Director, Research & Development at Vericel Corporation, Steven Walfish, Principal Consultant at Statistical Outsourcing Services
28th April 2025
Advancing Biomanufacturing Quality Control with GMP Next Generation Sequencing (NGS): Regulatory Insights and Industry Case Study
Presented by Amina Cherif Louazani, PhD, Viral safety and Regulatory affairs Manager at PathoQuest and Dave Briggs, Ph.D., Principal Scientist, Late Stage/Commercial at Avid Bioservices
22nd April 2025
Using Risk Management to Design Aseptic Process Simulations
Presented by Presented by Alberto Gonzalez, Global Sterility Assurance and Microbiology Associate Director at Takeda
16th April 2025
Design of a Global Risk-Based Personnel Monitoring Assessment for a Multi-Production Operation Company
Presented by Luyen Nguyen Global Sterility Assurance and Microbiology Lead at Takeda, Hilary Chan Global Sterility Assurance and Microbiology Lead at Takeda
10th April 2025
CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy
Presented by Sarah Thomas, Senior Vice President of Quality at REGENXBIO Inc.
27th March 2025
Grouping Extractable and Leachable (E&L) Compounds with a Common Mechanism of Action for Toxicological Risk Assessment
Presented by Ron Brown, Toxicologist at Risk Science Consortium, Philippe Verlinde, Ph.D. Senior Technical Advisor at Nelson Labs
25th March 2025
