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Old 2nd November 2012, 11:30 AM
JAMALUDEENBt
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Default FDA Audit Guidelines

Please guide me for do FDA inspection because I am new employee in this field and I have no experience of do audit so I ask you about guidelines of do audit if you know then please tell me about this
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  #2  
Old 3rd November 2012, 07:09 PM
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Join Date: May 2012
Default Re: FDA Audit Guidelines

I am giving the power point presentation of FDA audit preparation for your reference. Go through it. Notify your sponsor as soon as you are notified Notify IRB as soon as you are notified:
FDA may inspect the IRB if not previously inspected,or has not been inspected within past 5 years. Know your study staff
who is responsible for each step of study process?
ensure staff understands their on-going responsibilities
ensure all pertinent staff is available as needed

For the rest of the details you can download the presentation provided.
Attached Files
File Type: zip FDA Audit Preparation.zip (18.5 KB, 27 views)
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