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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

Teva discontinues Phase II emrusolmin trial in multiple system atrophy after futility analysis


Petosemtamab combination cuts risk of death by 50% in Phase III head and neck cancer trial


Roche launches VENTANA BAP1 test to support mesothelioma diagnosis


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Upcoming Webinars

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Past Webinars

Challenges Faced by the End Users During the Qualification of Single Use System

Presented by Ben Jeyaretnam (Ph. D., MBA), E&L Analytics Lead of Sanofi at Swiftwater and Dr Andreas Nixdorf, Team Manager / Business Development Manager R&D at SGS Group
14th January 2019


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

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


Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech
20th November 2019


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