Future of Analytical Procedures – ICH Q2(R2) & Q14: Development, Validation, & Lifecycle Management
Complimentary
Learning Level: Intermediate
Time: 1100 - 1230 ET
Session Length: 1.5 hour
The ICH guidelines, Q2(R2) – Validation of Analytical Procedures and Q14 – Analytical Procedure Development, have achieved Step 4 (Adoption of an ICH Harmonized Guideline) at the end of 2023. Implementation of the guidelines into the individual country regulatory frameworks (Step 5) will follow shortly. ICH content on analytical procedure validation has not experienced significant revision over the past 2+ decades. With this modernization of expectations, and the addition of new expectations, now is the time to learn more, to ensure that your analytical procedures are compliant with the new expectations. In addition, there are attractive elements contained in Q14 in regard to analytical procedure lifecycle management. In this webinar you will have the chance to hear directly from members of the ICH Q2(R2)/Q14 Expert Working Group, including both industry and regulatory perspectives on the principles defined in the documents and related case studies.
Learning Objective
- Gain a better understanding of ICH Q2(R2) and Q14 principles
- Examine case studies related to the application of these principles
- Learn about key areas of concern and potential from industry and regulatory perspective
