Transfer of Analytical Methods and Procedures according to USP 1224

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  • Опубліковано 13 жов 2024
  • When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain ‘the validated state’. Now the USP has published an updated general chapter . Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.
    For easy implementation, attendees will receive:
    SOP: Transfer of Analytical Methods
    Checklist: Transfer of Analytical Methods and Procedures
    Master Plan template and examples: Transfer of Analytical Methods and procedures

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