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.
- 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
Who will Benefit:
- Quality assurance personnel
- Quality control and method development analysts
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs personnel