Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.
Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.
This 2-day workshop will give attendees the background to understand the requirements, and even more significantly, it will focus on strategies and provide tools to implement most critical requirements. It will also provide templates and examples to develop inspection ready documentation. Interactive workshop exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions with real life examples. After the course a variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what attendees have learned in the course.
Learn about the regulatory background and requirements for validation of analytical methods and procedures
Learn how to plan, execute and document development and validation of methods developed in-house
Be able to explain the different requirements for validation, verification and transfer of analytical procedures
Understand the principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods
Be able to explain your company's strategy for method validation, verification, transfer and equivalency testing
Be able to select test parameters, test conditions and acceptance criteria for different analytical tasks
Be able to justify and document decisions about revalidation after method changes
Be able to define and demonstrate FDA and EU compliance to auditors and inspectors
Be able to develop inspection ready documentation during on-going routine operation
Understand statistical evaluation of validation test results
Understanding what questions will be asked during audits and inspections and how to answer them
Handouts/ Bonus Material for Easy Implementation (available as web downloads):
70-page primer: Validation of analytical methods (authored by Dr. Ludwig Huber)
10 SOPs related to validation, verification, transfer, review and change of analytical methods
10 checklists, templates and examples
Acceptance criteria for different analytical tasks