2014 Lifecycle Approach to Validation of Analytical Procedures Workshop
IQ Co-Sponsored Event
Sponsored by USP and AAPS
In the Stimuli article “Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification,” published in Pharmacopeial Forum(PF) 39(6), USP’s Validation and Verification Expert Panel discussed how the modern concept of lifecycle, based on the Product Life Cycle described in ICH guidelines Q8, Q9, and Q10 and the FDA Guidance for Industry Process Validation, can be applied to analytical procedures.
Through presentations, interactive roundtables, case studies, and open discussions, this workshop aims to help participants learn more about the lifecycle management of analytical procedures. In addition, the participants will be given the opportunity to provide feedback to the advisory expert panel on topics such as what training will be needed, what clarification is required, and how to move forward with the implementation of the lifecycle approach.
Quality by Design (QbD), the Product Lifecycle model applied to analytical procedures
Risk analysis/control strategy throughout the lifecycle
How to establish an analytical target lifecycle
Measurement uncertainty: what it is, how it is used in the analytical target profile, and how to estimate it
Case studies and examples
Statistical tools to support the development, qualification, and verification of the analytical procedure throughout the lifecycle
Current regulatory perspective