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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Risk Assessment for Single-Use Systems: USP 665 vs. BPOG

Published Date: March 23, 2022

Disposable plastic components of biopharmaceutical drug manufacturing systems are becoming more popular due to their cost and low contamination benefits. But the risk of using these components needs to be evaluated to determine impact to the final product. Historically each manufacturer has determined the risk by using understood risk-assessment processes, which have included established procedures, like those of BPOG (BioPhorum Operations Group), to frame a risk assessment. Currently USP has new draft sections, <665> and <1665>, that will give additional guidance regarding this risk-assessment process. The guidance will include recommendations for testing.

This webinar explores the principles behind BPOG and USP recommendations and offers insights on how to perform a single-use-component(s) risk assessment. The webinar also includes real-life examples of risk assessments and regulatory outcomes.

Learn about the presenters below.

Thor Rollins

Thor Rollins

BS, RM (NRCM)
Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Matthew Jorgensen

Matthew Jorgensen

PhD, DABT
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

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