Validation and Implementation of Alternate Sterility Tests for HCT/Ps

Description:

An online webinar training to provide guidance for manufacturers for the validation and implementation of alternate sterility testing methods of human cells, tissues, and cellular and tissue products (HCT/Ps) in a manner compliant with cGMPs and the new requirements in biologics regulation 21 CFR 610.12. Concepts for implementation of a sterility testing program are provided so that these tests are performed appropriately, are adequately investigated when deviations occur, and are maintained in a validated state over the product lifecycle, whether in the original test laboratory or transferred to other locations.

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