On Demand Webinars
Variability, Limits, and Other Considerations for the Next Generation of Pyrogen and Endotoxin Testing
Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions Lonza Walkersville, USA, Timothy Francis, Senior Technical Specialist for the LAL Division of FUJIFILM Wako Chemicals U.S.A. Corporation
06th February 2024
Proper Calculation of the Uncertainty Factors and its Application to the Analytical Evaluation Threshold and for Quantitation
Presented by Presented by Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions and Dr. Jan Baeten, Scientific Advisor R&D, Nelson Labs Europe
01st February 2024
mRNA Quality Assessment and USP Guidelines
Presented by John F. Cipollo, Ph. D. Team Lead and Senior Principal Scientist, Global Biologics at US Pharmacopeia and Khaled Yamout, Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies.
24th January 2024
Digital Transformation Journey in Process Development – Building Automated Data Flows, from Equipment to eLN to Advanced Analytics
Presented by Christian Airiau, PhD, Global Head Data Sciences, CMC at Sanofi, Pierre Lebrun, Director Statistics at Pharmalex and Arne Balzer, Life Science Informatics Consultant at Pharmalex
18th January 2024
AI and ML in Pharmaceutical Manufacturing – The Evolving Regulatory Environment in the GMP and CMC Reg Space in the US and Europe, Illustrated With Some Application Case Studies.
Presented by Dr. Gert Thurau, Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Roche
17th January 2024
Toxicological Risk Assessment on Extractables and Leachables
Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals and Dr. J. Susanne Becker, Director of Extractables & Leachables Laboratories at Intertek
16th January 2024
Leveraging Development and Commercial Knowledge for Root Cause Analysis of Commercial Near-infrared Methods
Presented by Brendon Lyons, Senior Scientist, Forensics and Innovative Technologies group in Global Quality at Bristol Myers Squibb and Joseph Andrew, Innovations Engineer at Optimal Industrial Technologies
11th January 2024
HCP Analysis in Biopharmaceuticals by Mass Spectrometry
Presented by Annu Uppal PHD. Director-Scientific Affairs & Strategy at USP and Anita Krishnan, Head of Analytical Sciences in Biocon Biologics
08th January 2024
Extractables Testing of Medical Devices Insights into Practical Issues
Presented by Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions and Pieter Van Wouwe PhD, Senior Expert E&L at Nelson Labs
05th December 2023
British Pharmacopoeia’s ATMP Guidance
Presented by Clare Blue, Senior CMC Translation Consultant eXmoor Pharma, Ryan Smith, British Pharmacopoeia Specialist at Medicines and Healthcare products Regulatory Agency and Lily Li, Lead Scientist, Analytical Development at AviadoBio
23rd November 2023
