Standardized Extractables Testing for Single-Use Systems
Single-use technologies (SUT) have evolved into commercial operations and drug manufacturers look for solutions to industrialize its usage in a safe and reliable way.
With single-use systems (SUS) adoption, quality ownership involves shared responsibilities between supplier and end user. Additional parts of the supply and quality chain shift to supplier.
Join us as we present existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle.
In this webinar, the fundamental principles of Quality Risk Management (QRM) applied to SUS adoption and validation will be discussed. In addition, participants will gain an in-depth understanding of how to define an integrity strategy for their critical SUS, as well as on how to safely Pre-Use Post Sterilization Integrity Test (PUPSIT) filters in SUS. By the conclusion of the session, all attendees should be able to define a risk mitigation strategy for SUS.
VP Technical Communication & Regulatory Strategy
Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation.
She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.
Sarah Jeffkins has been working in the Biotechnology Industry since 1988 when she joined Beecham Pharmaceuticals (now GSK) as a Fermentation Analyst.
During her 29 years working for GSK, she has undertaken a variety of roles within Upstream Operations (Fermentation), Downstream Processing (Extraction & Purification), Analytical and Quality. Sarah also had a role as Analytical Team Leader within a Technical Group where she developed her skills for managing a team, motivating and developing people whilst meeting tough objectives.
Sarah became the manager of the Analytical Laboratory at Pall Harbourgate facility in 2018, where she co-ordinates the extractable and leachable testing for Europe.
Senior Technical Specialist
Alain Vanhecke is a senior technical specialist for Pall Biotech based in Hoegaarden, Belgium. With over 33 years of experience in the bioprocessing industry, Alain is a critical driver of the extensive support program Pall provides for customers. He is responsible for multiple facets of integrating the bioprocess portfolio with scientific and laboratory services, including process development for strategic accounts and technical field support for the single-use technology portfolio in the European and Western regions.
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With the publication of the new chapters in USP <665> due in September 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!