How to validate to an existing international standard
Did you miss Randy Troutman's presentation at the HealthPack® 2007 conference? Download it now to learn more about how to validate to an existing international test standard.
The presentation includes:
FDA, ISO 11607, and QSR validation qualifications
how to establish a rationale for selecting a test method and acceptance criterion
how to determine test method repeatability and reproducibility; and how to determine sensitivity for integrity tests
strength and integrity package test method validation
