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  • 1.  FDA Boot Camp

    Posted 02-Oct-2017 16:27
    Hello, Everyone, 
    Anyone know about FDA boot camp training anywhere possibly in Washington DC? I wanted to get the training face to face as I heard some FDA instructors do give official training at Washington DC, any help and leads appreciated.
    thanks,Amna219-484-7696

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    Amna Shamim
    San Antonio TX
    United States
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  • 2.  RE: FDA Boot Camp

    Posted 03-Oct-2017 09:57
    The closest thing to this is likely to be one of the many reviews for the RAC exam. If your RAPS chapter in Texas doesn't have one, ask them to do it. Or you could attend one of the many on the East Coast or California. Sometimes even with the airfare the RAPS class is cheaper than a privately sponsored "Bootcamp" class.

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    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
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    Original Message


  • 3.  RE: FDA Boot Camp

    Posted 03-Oct-2017 11:26
    thanks a lot. I heard there are some FDA boot camp in Washington that's why I have asked:)

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    Amna Shamim
    San Antonio TX
    United States
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    Original Message


  • 4.  RE: FDA Boot Camp

    Posted 04-Oct-2017 08:03
    Edited by John Minier 04-Oct-2017 08:11
    There was a 2 day free conference last week that covered a lot of topics for those starting out in RA.  This is sometimes called FDA Boot Camp.  There is a drug track and a device track.

    FDA Small Business Regulatory Education for Industry (REdI): Fall Conference September 27-28, 2017

    There may be another one coming up in the Spring if you want to attend in person.  In the mean time you can download the slides or watch the recorded presentations.

    Past SBIA Events | SBIA Events


    Regards,

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    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
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    Original Message


  • 5.  RE: FDA Boot Camp

    Posted 04-Oct-2017 09:31
    ​There is also an "FDA Bootcamp" run by the American Conference Institute that is done in late winter or early spring.

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    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


  • 6.  RE: FDA Boot Camp

    Posted 04-Oct-2017 10:55
    let me look at it, any idea about their dates?

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    Amna Shamim
    San Antonio TX
    United States
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    Original Message


  • 7.  RE: FDA Boot Camp

    Posted 04-Oct-2017 10:55
    Wonderful, unfortunately I have missed it, any idea if they have more like this conference in the future.

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    Amna Shamim
    San Antonio TX
    United States
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    Original Message


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