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.
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
Who will Benefit:
QA managers and personnel
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