Best Practices to Prepare for and Manage FDA Inspections

Overview:

Preparing for and managing an FDA Inspection; the actual flow of company activities and roles; the inspection process, and the impact of non-compliance to FDA requirements on the medical devices/pharmaceutical firms, competiveness in the market, revenue, distribution, reliability status, and partnerships with suppliers, among others. It will also provides the challenges from the results of an inspection, in preparing and managing an inspection, and the benefits of successful results from an FDA inspection.

Why you should Attend: 

This course is designed to provide participants with an understanding of the purpose of FDA Inspections, the consequences of not complying with their requirements and how to prepare and manage these types of inspections. It will provide details on each topic from the course outline

Areas Covered in the Session:

• Purpose of FDA Inspections
• How Does FDA Decide Who to Inspect
• Inspection Frequency, Relationship to PMAs/NDAs/BLAs and Reference to the Inspection Model
• FDA Enforcements
• Example of DOJ Pharma/Device Settlements
• QSIT (Devices) Overview
• How Does "QSIT" Relate to the Pharmaceutical Industry
• Preparation for an FDA Inspection
• Inspection Process: What to Expect From FDA's Arrival Up to Their Exit
• Timelines to Respond to 483s, Warning Letters and Sequence of Response
• Inspection Findings-Trends
• Examples of Inspectional Findings on Warning Letters
• Challenges
• Conclusions

Who Will Benefit:

• Quality Auditors
• Compliance Officers
• Executive Management
• Managers/Directors/Supervisors and Personnel related to:
• • Regulatory Compliance and Regulatory Affairs
  • Quality Management System
  • Quality Assurance
  • Quality Control
  • Product Development
  • Engineering
  • Manufacturing
  • Risk Management
  • Complaint Handling
• Personnel New to the Regulated Industry
• Training Personnel
• Document Control Personnel