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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

Mo-Rez shows 62% response rate in platinum-resistant ovarian cancer


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


FDA expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


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Upcoming Webinars

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Past 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, Kevin L. Williams, Microbiological Test Development at bioMérieux, Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, Veronika Wills, Manager, Technical Services at Associates of Cape Cod, Inc and Allen L. Burgenson, Global Subject Matter Expert, Testing Solutions at Lonza 
02nd February 2023


Preview of USP’s Informational Chapter <1085>, “Guidelines on the Endotoxins Test”

Presented by Karen Zink McCullough & Kevin L. Williams
11th June 2018


The Use of Stability Modelling to Support Accelerated Vaccine Development & Supply

Presented by Didier Clenet, Research Scientist Formulation & Stability chez Sanofi Pasteur, Jos Weusten, Senior Statistician and Applied Mathematician at MSD (Oss, The Netherlands), Marilena Paludi, Lead Statistician presso GSK, and Cristiana Campa, Technical R&D Advisor at GSK
16th May 2022


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