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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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JSR Life Sciences



Headline News

Novo Nordisk’s once-weekly Sogroya receives positive CHMP opinion in Europe for children with idiopathic short stature


FDA approves Kerendia for chronic kidney disease linked to type 1 diabetes


CHMP recommends EU approval of FREHEMGO as the first factor VIIIa mimetic to offer monthly, biweekly, and weekly dosing through a pre-filled pen for haemophilia A treatment


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Upcoming Webinars

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Past Webinars

Validation of Microbiological Methods – Expectations for Regulatory Compliance

Presented by Dr. Rajesh K. Gupta Scientific & Compliance Consultant and Alan Hoffmeister, Global Field Technical Manager for Charles River
22nd May 2015


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

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


Rapid Microbiology Applications in the COVID-19 Era

Presented by Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC, Ulrich Herber Director of Technology and Market Development Charles River and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
04th August 2020


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