Integrity of Single-Use Systems
Single-use technologies (SUT) have evolved into commercial operations, and drug manufacturers are looking for solutions to industrialize their usage in a safe and reliable way.
With SUT 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.
Participants will learn:
- How to implement and validate SUS using Quality Risk Management (QRM)
- Define a reliable integrity strategy for SUS
- Pre-Use Post Sterilization Integrity Test (PUPSIT) for filters in SUS
- Simplify validation and toxicological assessment using standardized extractable data sets
Speaker
Hélène Pora
VP Technical Communication & Regulatory Strategy
Pall Biotech
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.
Patrick Evrard
Senior Principle Engineer
Pall Biotech
Patrick Evrard joined Pall Biotech in 2017, as Senior Director, SLS Single-Use Technologies, to manage the technical team providing expert technical support to Pall Biotech's customers. Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems.
White paper: A risk based approach to validation studies for sterilizing filtration. Download Now.
Biotech | Pall Corporation 웨비나 시리즈
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