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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...

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Headline News

FDA grants Priority Review to BRUKINSA combination in first-line mantle cell lymphoma


CAPLYTA shows rapid improvement in bipolar mania in second pivotal Phase III study


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


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Past Webinars

FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing

Presented by Lily Koo, Consumer Safety Officer at Food and Drug Administration and Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech, Analytics Lead
16th October 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


Smart machine learning solution to master industry 4.0 in biopharma

Presented by Moritz von Stosch, PhD,
11th November 2020


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