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Sterility Assurance for Sensitive Combination Products: Defining a Regulatory Path


Byron Lambert (Senior Associate Fellow, Sterilization Science, Abbott Vascular)

Location: 210D

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:

    • Update on a recently initiated AdvaMed Interest Group focused on defining predictable regulatory pathways for sterilization of sensitive combination products and biologics
    • Case studies of complex combination products and sterility assurance options
    • Risk assessment frameworks and options for bringing valuable products to market