On Demand Webinars

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