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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


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


Intranasal foralumab reduces microglial activation in Phase IIa progressive MS trial


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Past Webinars

Digitally Transforming Pharmaceutical Process Development and Manufacturing: Enabling Technologies for a Sustainable Future

Presented by Moiz Diwan, Moiz Diwan, Ph.D. Process Research and Development, AbbVie Inc., North Chicago, IL
04th October 2022


A risk based approach to continuous processing

Presented by Rob Bowen, Chair of the UK Central Region of ISPE and co-chair of the ISPE HVAC and Sustainable Facilities Community of Practice.Process Architect and Director,Facilities Integration
14th May 2015


Qualification of Raw Materials and Cell Substrates for Biomanufacturing

Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia and Martin Wisher, PhD, Global Head of Regulatory Affairs at Merck
16th January 2020


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