Validation Master Plan (VMP)

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  • Опубліковано 26 січ 2024
  • #pharmaceutical #csv #csa #validation #quality #qrm #riskmanagement #fda #compliance #gmp #ich
    This session will make you understand the "Validation Master Plan (VMP)" requirements in line with the various guideline expectations for example - EUGMP annex 11, 21 CFR Part 11, GAMP5, PIC/S guide etc.
    The agenda for this session is as below;
    Importance of topic
    Know your Trainer
    Guideline Requirements - EU,FDA, GAMP
    Validation Master Plan Preparation
    Key elements of VMP
    Common non-conformities with the VMP
    Q&A
    Vote of Thanks and contact details
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  • Наука та технологія

КОМЕНТАРІ • 9

  • @mohdbaseem46
    @mohdbaseem46 6 місяців тому +1

    Sir good Evening🙏🏼
    Sir please share the training presentation 🙏🏼🙏🏼

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  5 місяців тому

      Dear all, you can download the presentation by using this link: we.tl/t-u0fMIaTXFb
      Kindly note that, this link will be valid for 4 days only. So, hurry up...

  • @Bharatpithiyalive
    @Bharatpithiyalive 4 місяці тому +1

    Please share FDA guidelines for Gujarat

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 місяці тому +1

      There is no different guideline for different states. The guidelines are specific to specific countries. For example, for India, Schedule M.

    • @Bharatpithiyalive
      @Bharatpithiyalive 4 місяці тому +1

      ​@@hitendrakumarshah3718ok.... Thanks
      Is CDSCO and FDA same guidelines i.e. scheduled M?

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 місяці тому +1

      @@Bharatpithiyalive CDSCO will refer WHO guideline also while FDA person refers Schedule M

    • @Bharatpithiyalive
      @Bharatpithiyalive 4 місяці тому +1

      ​@@hitendrakumarshah3718ok.. Sir thank you.... Please help Where can find WHO guidelines?

    • @hitendrakumarshah3718
      @hitendrakumarshah3718  4 місяці тому +1

      @@Bharatpithiyalive I suggested you can visit WHO website. You will get current guidelines

  • @hitendrakumarshah3718
    @hitendrakumarshah3718  5 місяців тому

    Dear all, you can download the presentation by using this link: we.tl/t-u0fMIaTXFb
    Kindly note that, this link will be valid for 4 days only. So, hurry up...