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 Biotech 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

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 hunt

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

James Hathcock, PhD

 

‌Senior Director of Regulatory and Validation

Pall Biotech

James Hathcock, PhD is Senior Director of Regulatory and Validation Strategy at Pall Biotech, 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.

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

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Case Study: Swissfillon’s Approach to Single-Use Formulation & Filling

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In 2019 Swissfillon were inspected and approved by the FDA to supply drug products into the USA, following on from EU approval in 2018. This young fill finish CMO was started in Switzerland in 2013 and built a state-of-the-art cGMP production facility from the ground up.

Swissfillon recognized early on that single-use systems met their requirements for multi-product manufacturing and would help their clients get their drugs to market faster.

During this case-study webinar, participants will learn:

  1. How working in partnership with a supplier can be part of a QbD approach to minimize risk
  2. Strategies & design improvements for single-use systems to reduce risk in the process
  3. How a shadowboard can be used to make single-use system leak tests, PUPSIT and the filtration process fast, safe and simple
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