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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 expands TALZENNA plus XTANDI approval to earlier metastatic prostate cancer setting


Jemperli achieves 76% complete response rate in Phase II rectal cancer trial


FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease


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Upcoming Webinars

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Past Webinars

Integrity Assurance for Single-Use Systems: End-User Perspective

Presented by Charlotte Masy, Senior Manager in Manufacturing Science and Technology GSK vaccines and Patrick Evrard, Senior Principal Engineer, Single-Use Technologies in Technical Communication and Regulatory Strategy, Pall Corporation
06th October 2021


Regulatory Approval of Three Rapid Microbiological Methods for MACI Product Release

Presented by John Duguid Senior Director, Research & Development at Vericel Corporation and Nicola Reid, Senior Product Manager at Charles River
08th November 2018


Extractables and Leachables have been used interchangeablely for too long. Are we still confused?

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharmaceutical Services
25th March 2019


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