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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. |
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