2020 - Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Understand the regulatory requirements for validation of analytical methods
Learn how to plan, execute and document development and validation of in-house methods
Be able to explain the different requirements for validation, verification and transfer of analytical procedures
Understand the principles of validation of in-house methods, verification of compendial methods and method transfer
Know how to demonstrate equivalence to compendial methods
Understand the important qualities of stability-indicating methods
Be able to select test parameters, test conditions and acceptance criteria for different analytical measurements
Know how to plan, justify and document revalidation after method changes
Understand important indicators of the suitability of a method for routine QC use
Understand approaches for the statistical evaluation of validation test results
Understanding what questions will be asked during audits and inspections and how to answer them