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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


Featured Articles

Changing Column Packing from an Art into a Science

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA 

Beyond Quality: PAT as a Catalyst for Carbon Reduction in Pharma

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan,Scientist, Global Manufacturing Sciences & Technology organization at Bristol-Myers Squibb

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Headline News

ZENBEXUS combination more than doubles median progression-free survival in Phase III multiple myeloma study


AbbVie’s Temab-A receives two FDA Breakthrough Therapy Designations in colorectal and lung cancer


FDA approves TUKYSA regimen as front-line maintenance treatment for HER2-positive metastatic breast 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


Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Presented by Thomas O’Connor, Scientist at FDA, Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech and Chris McCready, Lead Data Scientist at Sartorius
30th October 2020


Raw Material Sourcing and Qualification

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC
23rd November 2020


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