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 NAU Blue Verification Form 2018

Blue 2018-2025 Form

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Video instructions and help with filling out and completing NAU Blue Verification Form

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Instructions and help about NAU Blue Verification Form

all right good morning good afternoon and good evening for those online I'm the sono a 2 and today I will be presenting the pre-approval inspection process and this will be from the field inspectors prospective so before we begins like to take a poll by show of hands how many of you have been through an FDA inspection how many of you have been through a pre-approval inspection ok so this may be a refresher for some so this is the agenda for the presentation well first start by going over the pre-approval process then I'll go through the inspection objectives from the inspectors perspective and then I'll give you some tips on how you can prepare for the pre-approval inspection well first from background the regulatory basis for the pre-approval inspection comes from the Food and Drug and Cosmetic Act the pre-approval inspection program has been shaped by many FDA initiatives including the pharmaceutical cGMP for the 21st century initiative with focus on risk base

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