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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 approves Abbott’s Amplatzer Paraclose device for heart valve leaks


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


Impella registry analyses report lower mortality than CHIP-BCIS3 in high-risk PCI


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Past Webinars

Raw Material Lot Variability Challenges During Manufacturing of Biosimilars mab

Presented by Sekhar Reddy, DSP Lead for Biosimilars at Biocon MSAT
25th January 2019


Qualification of Raw Materials Used In the Manufacturing of Cellular Therapies

Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia and Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River
07th October 2019


Transformation of Toxicology data into Specific PDE’s

Presented by Kim Li, PhD, DABT, MPH Principal Scientist, EHSS Product Stewardship Toxicology at Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC
23rd April 2020


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