On Demand Webinars
Downstream Platform Process Development for AAV viral vectors; Challenges and Opportunities
Presented by Presented by Parag Kumthekar, Lead Gene Therapy Downstream Process Development at UCB
02nd October 2024
Adventitious Agent Testing For MMV: How Much Do We Really Know?
Presented by Maria Farcet, Head of Cell Culture, Virus Models & Serology in the Global Pathogen Safety / Global Quality team at Takeda, Amina Cherif Louazani, PhD, Viral Safety Manager at PathoQuest and Dr. Denise Teber, Scientific Expert of the PCR department at Charles River Laboratories
01st October 2024
Medical Device Chemical Toxicological Risk Assessments: Applying Toxicological Principles to Meet the Challenge
Presented by Alan Hood, Toxicologist at the US FDA/CDRH/OPEQ and Sandi Schaible, Executive Director, Analytical Chemistry and Regulatory Toxicology at WuXi AppTec
23rd September 2024
Established Conditions in Analytical Procedure: Overview, Regulatory Examples and an FDA Laboratory Study
Presented by Jinhui Zhang, Chemist at FDA/CDER, Dimple Shah, Pr. Scientist at Waters Corporation and Dr. Phil Koerner, Global Pharmaceutical Market Development Manager at Phenomenex
17th September 2024
A Future of Microbiological Quality Levels and Managing Risk Release
Presented by John R. Logar, Senior Director, Sterility Assurance at Johnson & Johnson, Sebastian Scheler, Co-Founder, Managing Director, Chief Methodologist, Frame-by-Frame Risk Profiling Supervisor at Innerspace
12th September 2024
Analytical Assessment of Leachables in Biological Drug Products: FDA Approach in Reviewing Information
Presented by Andrey Sarafanov; PhD., Principal Investigator at U.S. FDA, Center for Biologics Evaluation and Research, Sona Kovackova, PhD, Scientific Expert – E&L at Nelson Labs, and Tine Hardeman, Manager Material Development bij at Datwyler
04th September 2024
Application of Portable Spectrometers in Pharmaceutical Forensics
Presented by Brittany Handzo, Scientist, Forensics and Innovative Technologies at Bristol-Myers Squibb and Ravi Kalyanaraman, PhD, Director of the Forensics and Innovative Technologies at Bristol-Myers Squibb
27th June 2024
Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
Presented by Irina Ramos, Director, Bioprocess Technology and Engineering at AstraZeneca, Elizabeth Goodrich, R&D Technical Director at Merck, Kurt Boenning, R&D Engineer II at Cytiva and Paul Gillham, Innovations Director at Optimal Industrial Technologies
18th June 2024
Building the House of Rapid Sterility – A Successful Platform Approach to introducing Rapid Methods
Presented by Sophie Drinkwater, Senior Scientist in Microbiology at AstraZeneca, Jon Kallay, Senior Scientific Portfolio Specialist, Charles River Microbial Solutions
18th April 2024
Validation of Test Result Equivalence for Alternative BET assays, Including Recombinant Methods
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, Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza and Alan Hoffmeister, Senior Global Technology and Market Development Manager at Charles River
27th March 2024