Drug development
Authority for FDA Inspections
New Drug Application NDA
The scope of FDA Compliance Program
Legal scope and limits of FDA inspections
Current FDA Positioning / ‘Threats’
Types of Inspection
Quality control validation and sampling types
Biotest sample collection & analysis
NDA and Process validation
How to get a quick Assessment of a Company State of Compliance
Preparing for a GMP Inspection
Auditing Your Company to prepare for international Inspections
Industry Best Practices for Managing Inspections
Fundamentals of a Systems-Based Inspection
Implement and Maintain an Effective Customer Complaint System
Before the Inspection
Preparing for the PAI
Improving/Preparing your CAPA and Investigations Systems for Inspection
Basic survival rules
Prime Inspection Targets
Scale Up Post Approval Inspection
Warning letters 483
18(hours)