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19-Sep-2019 - 20-Sep-2019

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

  • Location:
    • Venue to be announced shortly
    • Boston
    • MA
    • 02101
    • United States
  • View on a map

This 2-day workshop will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols. The course includes workshops to help attendees plan method validation and to select appropriate acceptance criteria, as well as checklists for validation protocol and analytical method contents.

Learning Objectives:

  • Understand the regulatory requirements for validation of analytical methods
  • Learn how to plan, execute and document development and validation of in-house methods
  • Be able to explain the different requirements for validation, verification and transfer of analytical procedures
  • Understand the principles of validation of in-house methods, verification of compendial methods and method transfer
  • Know how to demonstrate equivalence to compendial methods
  • Understand the important qualities of stability-indicating methods
  • Be able to select test parameters, test conditions and acceptance criteria for different analytical measurements
  • Know how to plan, justify and document revalidation after method changes
  • Understand important indicators of the suitability of a method for routine QC use
  • Understand approaches for the statistical evaluation of validation test results
  • Understanding what questions will be asked during audits and inspections and how to answer them

Who will Benefit:

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