Regulatory Open Forum

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  • 1.  Facebook monitoring

    Posted 30-Sep-2015 18:23

    Hello, 

    My company manufactures medical device (ii) and a drug. We are trying to provide regulatory oversight on social media, in particular two way communication on Facebook. 

    Trying to see how other company professionals handle this and how often (weekly/monthly)to provide Regulatory oversight. 

    Really appreciate your feedback on this. 

    Best,

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    Sartaj Kaur-Hurrle
    San Diego CA
    United States
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  • 2.  RE: Facebook monitoring

    Posted 30-Sep-2015 18:52
    Sartaj,

    We've been doing research on social media. Due to our associate's great work, we've been able to offer our social media online seminar program at <https://www.globalcomplianceseminar.com/event/good-social-media-practices-to-avoid-fda-actions/>

    Please have a look at the link!

    It is imperative to establish FDA-compliant social media practices (Twitter, YouTube, Facebook, WordPress, Blogger).  

    Thank you.  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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  • 3.  RE: Facebook monitoring

    Posted 01-Oct-2015 12:04

    Overall, I'm not a big fan of having social media interface with medical device or drug companies.  While there is wealth of information (good and bad) that can be collected from social media, there is too much compliance risk IMO.

    For example, I had a client that received a 483 because someone complained about one of their products (medical device) on the company facebook page.  It was a rather mundane complaint, but it wasn't processed per 820 regs and they got an observation.  We assessed all forms of social media, including Amazon, and found that the level of resources needed to oversee social media was too much and too risky.  The client ultimately decided to block all external post on Facebook.

    Just food for thought...


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    Christopher Wilson RAC
    Chicago IL
    United States
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    Original Message