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Byron Lambert (Senior Associate Fellow, Sterilization Science, Abbott Vascular)
Date: Thursday, February 8
Time: 9:15am - 10:00am
Pass Type: Conference (Paid) - Get your pass now!
Conference Track: MD&M: Regulatory & Quality Update
Vault Recording: TBD
The medical device community is faced with a significant challenge: how to provide sterility assurance for sensitive combination products and biologics. In response, the industry is developing new sterilization technologies, new sterilization validation paths, and new regulatory paradigms. This session will provide an overview of a new risk-based ISO guidance document, ISO TS 19930, available to use in navigating an approval path for an alternative Sterility Assurance Level (SAL) with regulatory bodies when it is not possible to terminally sterilize a combination product or biologic with a traditional maximal SAL of 10-6.
Topics to be covered include: