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

Topics

• 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

Who should Attend

• Quality control
• QA managers and personnel
• Analytical chemists
• Method development
• Laboratory managers and supervisors
• Validation specialists
• Training departments
• Regulatory affairs
• Consultants
• Documentation departments