Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) is a webinar dedicated to regulatory requirements for method validation, verification and transfer.
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) covers topics such as:
- How to plan , execute and document development and validation of in-house methods
- The regulatory requirements for validation of analytical methods
- The principles of validation of in-house methods, verification of compendial methods and method transfer
- The different requirements for validation, verification and transfer of analytical procedures
- The important qualities of stability-indicating methods
- How to demonstrate equivalence to compendial methods
- How to plan , justify and document revalidation after method changes
- Test parameters, test conditions and acceptance criteria for different analytical measurements
- Approaches for the statistical evaluation of validation test results
- Important indicators of the suitability of a method for routine QC use
- What questions will be asked during audits and inspections and how to answer them
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) brings together:
- Quality control and method development analysts
- Quality assurance personnel
- Laboratory managers and supervisors
- Validation specialists
- Consultants
- Regulatory affairs personnel