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

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.

Topics

• 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

Who should Attend

• Quality control and method development analysts
• Quality assurance personnel
• Laboratory managers and supervisors
• Validation specialists
• Consultants
• Regulatory affairs personnel