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Application of Quality Risk Management to Process Validation

Robert Dream, Managing Director, HDR Company LLC

A Holistic Phase Appropriate Strategy for HCP-Limits and HCP Characterization

Dr. Markus Haindl, Global Head Gene Therapy Technical Research & Development, Roche Di...

Strategies for Extractable and Leachable Risk Assessment of Polymeric Single Use Systems U...

Ping Wang, Director, Johnson & Johnson

Use of Non-Contact Raman Spectroscopy to Derive Reaction Kinetics

Richard Hart, Senior Director – Head of Automation and Data Science (Previously Asso...

Amsphere A3

JSR Life Sciences



Headline News

FDA grants Priority Review to uniQure’s Huntington’s disease gene therapy


Lilly and Hims & Hers expand access to Zepbound and Foundayo


Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines


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Past Webinars

Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
07th March 2022


The Journey to Lean Implementation for Efficiency Increase

Presented by Uwe Voelker, Site Head, Sterile Drug Product Manufacturing at Roche
04th September 2019


DSF and FTIR as complementary methods for the identification and characterization of vaccine products

Presented by Marina Kirkitadze, Deputy Director, Head of Biophysics & Conformation Unit, Analytical R&D Biochemistry, Sanofi Pasteur and Rina Dukor, President, BioTools
18th September 2018


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