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What's the spookiest thing a regulatory professional can hear?

  • 1.  What's the spookiest thing a regulatory professional can hear?

    Posted 31-Oct-2022 09:38
    πŸŽƒ Fill in the blank: ____ is the spookiest thing you can tell a regulatory professional.



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    Ryan Connors
    Social Media and Communications Specialist
    RAPS
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  • 2.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 01-Nov-2022 00:44
    "We've always done it this way, and we are not changing the process" (in response to new regulations).



    Original Message


  • 3.  RE: What's the spookiest thing a regulatory professional can hear?

    This message was posted by a user wishing to remain anonymous
    Posted 01-Nov-2022 08:43
    This message was posted by a user wishing to remain anonymous

    "Yes, we know that is the requirement, but we can argue that... [fill in the rest with an argument on why not do something in compliance]"
    Original Message


  • 4.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 02-Nov-2022 12:07

    "We are very proud of our internal audit program. Of course we let her (FDA Inspector) see the reports"

     

     

    Sent from Mail for Windows

     




    Original Message


  • 5.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 01-Nov-2022 03:31
    Hey, boss - an FDA team is at the door and their ID says they are from the Office of Criminal Investigations! Should I let them in?

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    Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
    Consultant
    United States
    ------------------------------

    Original Message


  • 6.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 01-Nov-2022 08:08
    From the FDA PM:  "Please make the Sponsor team available tomorrow afternoon at 2 PM for a phone call."

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 7.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 01-Nov-2022 08:17
    Yes....!!!  And those lovely interactive review requests....please a complete response by close of business tomorrow (COB).  Always sent on a late Thursday afternoon, during summer vacation season.




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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 8.  RE: What's the spookiest thing a regulatory professional can hear?

    This message was posted by a user wishing to remain anonymous
    Posted 01-Nov-2022 16:07
    This message was posted by a user wishing to remain anonymous

    U.S. Marshalls just came to padlock the door and perp-walk management out of the building.
    Original Message


  • 9.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 02-Nov-2022 07:23
    "FDA is wrong, that is not what the regulations mean."

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    Arvilla Trag RAC
    Principal Consultant
    CMC Compliance Services
    Iron River MI
    United States
    ------------------------------

    Original Message


  • 10.  RE: What's the spookiest thing a regulatory professional can hear?

    This message was posted by a user wishing to remain anonymous
    Posted 02-Nov-2022 10:42
    This message was posted by a user wishing to remain anonymous

    Overheard, "Don't tell Regulatory about it."
    Original Message


  • 11.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 03-Nov-2022 04:52
    "Oh, May 2024; then we have more than enough time!"

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 12.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 04-Nov-2022 13:38
    "2024? I'm not worried. They're probably going to delay it again!"

    ------------------------------
    Kimberly Chan
    Lansdale PA
    United States
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    Original Message


  • 13.  RE: What's the spookiest thing a regulatory professional can hear?

    This message was posted by a user wishing to remain anonymous
    Posted 03-Nov-2022 11:27
    This message was posted by a user wishing to remain anonymous

    I can't tell you how many times I've heard this...
    Original Message


  • 14.  RE: What's the spookiest thing a regulatory professional can hear?

    Posted 04-Nov-2022 13:34
    "That must be your opinion, we were audited before and it was never mentioned "; what regulation is that?

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    Lidia Brownell MHA
    VP Clinical Research and Regulatory
    Tacoma WA
    United States
    ------------------------------

    Original Message


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