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Fda

  • 18-05-2005 8:23pm
    #1
    zervi2003
    Closed Accounts Posts: 292 ✭✭


    Hello!

    Can someone please explain to me what FDA means in this sense?

    "Ensure site training compliance in line with FDA and ISO standards."

    Thanks


Comments

  • #2
    leeroybrown
    Closed Accounts Posts: 7,563 ✭✭✭leeroybrown


    Seeing as this is operations training, I'm guessing that this is a medical/biomedical company (with US customers or ownership) and that the FDA refers to the US Food and Drug Administration.


  • #3
    daveg
    Registered Users, Registered Users 2 Posts: 4,683 ✭✭✭daveg


    To add a medical device company that distributes it's products in the US will have to have FDA complience (audits etc). From distribution in europe ISO (ISO13485) complience is required and again the certification is obtained though an audit (yearly reaudits as well).


  • #4
    RicardoSmith
    Closed Accounts Posts: 8,264 ✭✭✭RicardoSmith


    Theres a whole world of FDA validation requirements that you have to satisfy for a whole range of activities.

    The idea is as follows. Making a cup of tea needs to be approved by 3 people, process approved and documented in triplicate and the records of tea making stored for 100 yrs. If breach of any of the requirements. The FDA can walk into the business and shut you down on the spot. Or issue a huge fine. That kinda thing.

    You need to find the regulations that apply to what you are doing and see whats required. I had to do some work on computer systems and paper based record handling before.


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