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all right good morning good afternoon and good evening for those online Iamp;#39;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 Iamp;#39;ll go through the inspection objectives from the inspectors perspective and then Iamp;#39;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
