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

 

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 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

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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October 2021

Integrity Assurance for Single-Use Systems An End-User’s Perspective

 

What should you consider when building an integrity control strategy for your single-use systems (SUS)? How do you overcome application challenges?

 

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective. They will present several case studies to show how integrity concerns can be practically addressed for cGMP manufacturing applications and the results observed a few years on. 

 

Attendees will learn about:

 

  • The latest regulatory requirements for integrity assurance of SUS
  • The different technologies available to control integrity of SUS
  • Key parameters that affect integrity measurements

 

Register now for this webinar from industry experts on October 6.

 

Watch