FDA医疗器械工厂检查 04COLEMAN-FDA+MD+inspection+process.pdfVIP

FDA’s MEDICAL DEVICE FDA’s MEDICAL DEVICE INSPECTION PROCESS INSPECTION PROCESS Presented By: Presented By: Karen A. Coleman Karen A. Coleman FDA INSPECTION PROCESS FDA INSPECTION PROCESS FDA Authority, Regulations, and Guidance FDA Authority, Regulations, and Guidance FDA Inspection/Audit Process FDA Inspection/Audit Process – Types of Inspections/Audits – Types of Inspections/Audits – Audit Closeout Meetings Findings – Audit Closeout Meetings Findings