Application of USP 665 data to support qualification of single use systems
With the publication of the new chapters in USP <665> on September 1st join Ken Wong from Sanofi Pasteur, Desmond Hunt from United States Pharmacopeia and James Hathcock from Pall to get the latest updates.
Participants will learn:
About the USP <665> standardized extraction solution protocol for manufacturing components and systems
What is new and what has changed in USP <665> and <1665> (as of September 2020)
The top issues influencing the alignment of the BioPhorum extractables protocol and USP <665>
What level of data end-users can expect to see
How to apply USP <665> data sets to support risk assessment and qualification of single-use systems
The opportunities ahead for simplifying the adoption of single-use technologies
Don’t miss this free BioPharma Asia webinar to hear from subject matter experts serving on the USP and BPOG panels!
Speakers
Ken Wong
Deputy Director of Process Technology
Sanofi Pasteur
Ken Wong is a Deputy Director of Process Technology Platform at Sanofi Pasteur. Serving as the Swiftwater site extractables and leachables (E&L) SME but also provide E&L supports to all global sites. In the last 10 years, he has been heavily involved with Single-Use Technology and actively participating in Disposable workstreams of BioPhorum Operations Group (BPOG), the USP <665> Expert Panel and the ELSIE material working group.
Dr. Desmond G. Hunt
Principal Scientific Liaison
USP
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He participates on several industry Working Groups and Technical Committees related to his areas of expertise.
James Hathcock, PhD
Senior Director of Regulatory and Validation
Pall
James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall, which includes responsibility for E&L characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA, Biophorum-supplier phorum as well a USP <665> expert panel member.
Explore the Pall Regulatory Support Portal
Download a sample extractables report, get our impurities risk assessment calculator, explore the list of available extractables reports for Pall-manufactured components and much more!
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