Table of Contents
Overview of Gene Therapy Surveillance Inspections
PURPOSE of BIMO
FDA’s 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
|