Validation, Verification and Transfer of Analytical Methods from FDA/EMA, USP and ICH 2017 is a conference that covers topics such as:
- How to plan , execute and document development and validation of methods developed in-house
- The regulatory background and requirements for validation of analytical methods and procedures
- The principles of validating methods developed in-house, verification of compendial methods, transfer of analytical procedures and demonstrating equivalency to compendial methods
- The different requirements for validation, verification and transfer of analytical procedures
- Test parameters, test conditions and acceptance criteria for different analytical tasks
- Your companys strategy for method validation, verification, transfer and equivalency testing
- FDA and EU compliance to auditors and inspectors
- Justify and document decisions about revalidation after method changes
- Statistical evaluation of validation test results
- Inspection ready documentation during on-going routine operation
- What questions will be asked during audits and inspections and how to answer them
Validation, Verification and Transfer of Analytical Methods from FDA/EMA, USP and ICH 2017 brings together:
- Quality control
- QA managers and personnel
- Analytical chemists
- Method development
- Laboratory managers and supervisors
- Validation specialists
- Training departments
- Regulatory affairs
- Consultants
- Documentation departments
