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  • 1.  OSD forum on ICH M10 Guidelines : OVERVIEW OF THE VALIDATION OF CHROMATOGRAPHIC ASSAYS

    Posted 08-24-2022 14:06

    Please join the AAPS Bioanalytical Community on September 12th@ 12pm EDT for an Open Scientific Discussion:

    ICH M10 Guidelines: Overview of the Validation of Chromatographic Assays

     

    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 validation of chromatographic assays.  Differences between the global guidance and the current regional guidance's will be reviewed and discussed.

     

    Presenters: Eric Woolf (Merck & Co., Inc), Stephanie Cape (LabCorp)

    Moderator: Chad Briscoe (Bioagilytix)

     

    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.


    https://meet.goto.com/670052085

    You can also dial in using your phone.
    United States: +1 (669) 224-3412

    Access Code: 670-052-085

    Join from a video-conferencing room or system.
    Dial in or type: 67.217.95.2 or inroomlink.goto.com
    Meeting ID: 670 052 085
    Or dial directly: [email protected] or 67.217.95.2##670052085

    Get the app now and be ready when your first meeting startshttps://meet.goto.com/install  

     

    #bioanalysis #Bioanalytical #OSD #OpenScientificDiscussions



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    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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  • 2.  RE: OSD forum on ICH M10 Guidelines : OVERVIEW OF THE VALIDATION OF CHROMATOGRAPHIC ASSAYS

    Posted 08-31-2022 09:54
    Thank you for setting this video conference in motion.  This will be beneficial to the bioa community. Will the link also be posted on LinkedIn?

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    Shane Needham
    Founder, President and CEO
    Veloxity Labs, LLC
    Peoria IL
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 3.  RE: OSD forum on ICH M10 Guidelines : OVERVIEW OF THE VALIDATION OF CHROMATOGRAPHIC ASSAYS

    Community Leadership
    Posted 09-01-2022 08:16
    Looking forward to this OSD!
    Yan

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    Yan Ni
    Senior Director
    Passage Bio
    Philadelphia 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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