On Demand Webinars
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
Microbial Impact Assessment of In-Process Bioburden Limit Excursions
Presented by Friedrich von Wintzingerode, PhD. Director, Microbiology and QC individualized and cell therapy at Genentech, Cheryl Essex, MS. Head of Contamination Control, R&D Global Quality at Sanofi and Jon Kallay, Senior Scientific Portfolio Specialist, Charles River Microbial Solutions
20th March 2025
Navigating the Complexities of mRNA Therapies Analysis: Challenges, Techniques, and Quality Assessment Strategies
Presented by Sarita Kattel, M.S, Principal Scientist, Global Biologics at USP, Khaled Yamout, CEO at Yamout Chem Consulting, LLC, Martin Gilar, Ph.D., Scientific Fellow, Seperations R&D group at Water Corporation, Roxanna Eggleston-Rangel, Applications Scientist at Phenomenex
27th February 2025
Case Study: A Risk-Based Approach to Material Transfer Validation
Presented by Presented by Liz Brockson, Aseptic Processing and Sterility Assurance Lead in Global Sterility Assurance and Microbiology at Takeda
19th February 2025
