03.10.2014 Views

FDA Inspectional Approach, Paul Bellamy (733 KB)

FDA Inspectional Approach, Paul Bellamy (733 KB)

FDA Inspectional Approach, Paul Bellamy (733 KB)

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START OF INSPECTION<br />

• BEST WAY TO START INSPECTION IS TO<br />

GIVE A OPENING COMPANY OVERVIEW<br />

PRESENTATION. GIVE PRESENTATION<br />

ORALLY AND PROVIDE HANDOUT TO<br />

INVESTIGATOR<br />

• ALSO PROVIDE INVESTIGATOR WITH<br />

BINDER OF ALL PERTAINENT<br />

INFORMATION<br />

6

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