Overview of Gene Therapy Surveillance Inspections

3/29/01


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Table of Contents

Overview of Gene Therapy Surveillance Inspections

PURPOSE of BIMO

FDAs BIMO Program

Bioresearch Monitoring Compliance Programs

When does BIMO become involved?

BIMO Involvement

PPT Slide

Site Selection Factors

Site Selection Factors

Assignment Content

Classifications

Correspondence

Administrative Actions

GT Inspections

GT Inspections

GT Inspections

GT Inspections

GT Inspections

GT Inspections

GT Inspections

GT Inspections

GT Inspections

GT Inspections a comparison

GT Inspections

GT Inspections most common deficiencies

Author: Joseph P. Salewski