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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

mNEXSPIKE associated with lower COVID-19 hospitalisation risk than Comirnaty in older adults


Taltz and Zepbound combination maintains improved psoriatic arthritis outcomes at one year


Pasritamig combination delivers 73% PSA response rate in advanced prostate cancer Phase I study


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Upcoming Webinars

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Past Webinars

Application of USP 665 data to support qualification of single use systems

Presented by Ken Wong, Deputy Director at Sanofi Pasteur and Desmond G. Hunt, Principal Liaison at United States Pharmacopeia and James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
01st September 2020


Sterile Products Manufacturing – prepared for the future?

Presented by Gert Moelgaard
15th February 2018


CCAB: Addressing the risk of microbial impurities in Biologics and certain Advanced Therapy Medicinal Products (ATMPs)

Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST (individual Neoepitope Specific Therapy), Roche and Nahuel Paolini, PhD, Sanquin Reagents
28th March 2022


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