Regulatory Open Forum

 View Only

  • 1.  Mock FDA Audit

    Posted 11-Sep-2023 09:03

    Greetings RegEx!

    We have a client that will have their first FDA inspection in November.  They wish to have a mock FDA inspection as soon as possible.  They are looking for someone located in the EU.

    Any recommendations for EU-based firms that can act quickly?

    Thanks for your feedback and recommendations.

    Melissa



    ------------------------------
    Melissa Walker FRAPS, RAC
    President & CTO
    St Louis MO
    United States
    ------------------------------


  • 2.  RE: Mock FDA Audit

    Posted 12-Sep-2023 06:11

    Hi Melissa,

    We are located in the Netherlands and have over 20 years of experience in assisting European companies with an ISO 13485-based quality system in preparing for and following up on FDA inspections: mock FDA inspections, development of strategy, assistance during inspections... I would be happy to discuss your client's needs.

    Angelika

    Business Support International



    ------------------------------
    Angelika Scherp
    Amsterdam
    Netherlands
    ------------------------------

    Original Message


  • 3.  RE: Mock FDA Audit

    This message was posted by a user wishing to remain anonymous
    Posted 12-Sep-2023 13:49
    This message was posted by a user wishing to remain anonymous

    Hi, Melissa - Does your client need a medical device or pharma mock FDA inspection?  That information may help determine who has the correct competency to assist.

    Anon


    Original Message


  • 4.  RE: Mock FDA Audit

    Posted 12-Sep-2023 15:35

    Medical Device company.  Heavy emphasis on software.

     

    Melissa

     

    Melissa Walker, MS, RAC, FRAPS

    President & CTO

    Graematter, Inc.

    1324 Clarkson Clayton Center

    #332

    St Louis, MO  63011

    Office: 636-405-7498

    Cell: 314-753-7790

     

    "Laugh hard.  Run fast.  Be kind."  - The Doctor

     




    Original Message


Related Content