Analytical method validation is crucial for product approval. Robust methods have always been the foundation of validation, which is further underscored by FDA’s new final guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” released in July of 2016.
Are you prepared to submit your analytical procedure and methods validation data in accordance with new FDA recommendations? Do you know what you need to do in order to prepare, assemble, and present information in a manner that thoroughly supports your analytical methodologies?
While ICH Q2 (R1) remains the primary Guidance for Method Validation, this information-packed new Final Guidance document details exactly what your submission must have.
At the conclusion of this 90-minute session, participants will be able to:
- What FDA expects to see in every method procedure you submit
- The reference standards and other reference materials FDA expects you to have
- FDA expectations for verification of compendial methods
- FDA expectations for validation of stability-indicating methods
- FDA’s expectations for life cycle management of analytical procedures