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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

Pfizer’s 25-valent pneumococcal vaccine shows robust immune responses in Phase II infant study


Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal cancer


Sofe-M combination shows 79% response rate in platinum-sensitive ovarian cancer


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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


Challenges and Risks in Development and Manufacture of Covid 19 Vaccines

Presented by Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC, North Potomac, Harish Rao, General Manager at Serum Institute of India Ltd, Amar Shrivastava, Senior Manager  at Serum Institute of India Ltd
30th June 2020


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

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


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