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  1. #1
    Validation Analyst
    Join Date
    Jun 2008
    Posts
    10

    Wink usfda guidelines

    can anybody provide me USFDA GUIDELINES OR CAN TELL ME THE BEST WEBSITE FOR THAT.



    thanks

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  3. #2
    Validation Guru
    Join Date
    Oct 2007
    Posts
    351

    Default

    What, exactly, are you looking for? You should have been able to do a simple search to turn up the FDA home page:

    http://www.fda.gov/

    From there, you can branch off to the division of interest. For example, if you need medical device information, there's a link on that page for devices that allows you to (mouse-over and) select topics such as guidelines or device advice.

  4. #3
    Validation Analyst
    Join Date
    May 2008
    Posts
    11

    Default

    Dear Gagandeep,

    You can refer to the below mentioned search engine in FDA site. You should be able to get what you are looking for.

    http://www.fda.gov/search.html

  5. #4
    Validation Guru
    Join Date
    Oct 2010
    Location
    Copenhagen,Denmark
    Posts
    1,798

    Default

    Reading FDA guidelines is one part and understanding them and putting into actual implementation is another level.

    Just reading FDA guidelines does not make any one of us bigger or greater.

    It all depends up on the applicability to that present situation at your facility, process, release and or testing.

    We can convince the regulatory authorities with some of the practices in the shop floor if we have strong science bhiend our inhouse developed techniques. How we validate those unique or new techniques and how we present them with strong statistical data is what FDA looks.

    FDA auditors are open for new insights from industry.
    The new procedures must be well documented and should follow all quality practices.
    Durga Prasad

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