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OSD on ICH M10 Guidelines: Additional Considerations, Documentation, and Reporting

  • 1.  OSD on ICH M10 Guidelines: Additional Considerations, Documentation, and Reporting

    Posted 09-14-2022 17:27

    Please join the AAPS Bioanalytical Community on October 3rd @ 12:00 pm EDT for an Open Scientific Discussion:

     

    ICH M10 Guidelines: Additional Considerations, Documentation, and Reporting

     

    The sign-off of ICH M10 by regulators marks the culmination of a long effort to develop a global guidance for bioanalytical method validation.  While a global guidance will, in the long run, benefit the bioanalytical community, in the short term, labs will need to align their practices and procedures with the new guidance.  This OSD will review the sections of ICH M10 related to the additional considerations, documentation, and reporting sections of M10.  Differences between the global guidance and the current typical practices within the bioanalytical community will be reviewed and discussed.

     

    Presenters: Steve Lowes (Q2 Solutions), Robert Dodge (Novartis)

    Moderator: Sanjeev Bhardwaj (Janssen)

     

    For more information, including calendar invites, and virtual meeting login info,
    please visit the EVENT PAGE Admission is free, so invite your friends!

    LinkedIn Link

     

    Please join my meeting from your computer, tablet, or smartphone using the Desktop App of GoToMeeting.


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    #bioanalysis #Bioanalytical #OSD #OpenScientificDiscussions



    ------------------------------
    Sanjeev Bhardwaj
    Janssen R&D
    Spring House, PA
    [email protected]]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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