Regulatory Open Forum

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  • 1.  Q-Sub Supplement

    Posted 22-Oct-2019 19:22
    Is a full paper copy and company letterhead cover memo with wet signature required for a Q-Sub Supplement?

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    Robert Wilkinson
    President
    Port Barrington IL
    United States
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  • 2.  RE: Q-Sub Supplement

    Posted 23-Oct-2019 02:40
    Robert,

    No, you can send in a Q-Sub supplement via eCopy as well.  What I have done with Q-Sub Supplements is make sure they follow the eCopy specification on a USB stick or CD/DVD with the numbering 001_, 002_, etc., and then I just include a very short hard copy letter with the USB stick/CD/DVD stating what the eCopy is for.  There is no reason to send in a full hard copy.  And depending on what exactly is the supplement, I have also sent in very short ones only electronic through email.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Q-Sub Supplement

    Posted 23-Oct-2019 15:22
    Thanks Richard,

    I have always foud your advice to be very accurate. Thanks again.

    Bob

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    Robert Wilkinson
    President
    Port Barrington IL
    United States
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    Original Message


  • 4.  RE: Q-Sub Supplement

    Posted 23-Oct-2019 08:45
    Our last Q-sub supplement was email with attachments, and it was accepted and reviewed by the agency.

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    Joshua Lust
    Senior Quality & Regulatory Affairs Manager
    Grand Rapids MI
    United States
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    Original Message


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