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

Description

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

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Please, check the official conference website for possible changes, before you make any traveling arrangements

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