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Tag: "Validation" - Expert Advice Community



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  • Clause, Changes to a validated Method.

    If a validated and published method (e.g. FDA, EPA, etc.) says that we can adjust parameters as necessary, e.g. column conditions, and we do choose to alter those parameters, is that considered a change to a validated method despite the method stating that we can indeed alter those parameters?

  • Training Validation for ISO 13485

    I'm wondering how in depth I need to be in regards to training validation. Our training consists of reading the SOPs, and then signing off on their personal training records. My predecessor suggested creating an assessment quiz for each SOP, but it seems a little more labor intensive than the standard requires. I am thinking it might be more beneficial to create QMS assessment quizzes for certain processes (manufacturing dept, shipping dept, etc.) and then testing on a quarterly basis for comprehension and retention. ISO 13485 doesn't specifically say how this should be handled. I would appreciate any suggestions or feedback. Thank you!