FDA Inspections: the Good the Bad and the Ugly 

From the 2019 CCTS FDA Conference:
Michele Bright, assistant Director of the Ohio State College of Medicine Clinical Trials Organization, discusses FDA inspections. She discusses their impact, prevention and preparation tips when dealing with an FDA inspection, potential outcomes from FDA inspections, common findings of FDA Inspections, and lessons learned from a career in clinical trials research and collaborating with the FDA.

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