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 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 (Understanding and implementing guidelines from FDA/EMA, USP and ICH) 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

Important

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

Prices are for evaluation only.

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