Lifecycle Management of Analytical Method Validation in Compliance with the FDA, ICH and USP Expectations

Analytical laboratories play key roles in the pharmaceutical industry. The generation of data that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; thus, keeping the analytical method in compliance with FDA, ICH and USP regulations is a challenge for analytical scientists.
This course will review the current regulations from FDA, ICH, USP, and WHO, and different aspects of validation throughout development phases to establish critical acceptance criteria. It will also discuss change strategies to analytical procedures, especially the difference of validation, verification and transfer. Key experiments will also be discussed to establish different validation parameters. Participants are expected to share their experiences and discuss lab practices to keep method stay in compliance.