This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.
At the end of the webinar, attendees will become familiar with the FDA inspection process to ensure proactively preparing for and better managing FDA inspection matters in a much less burdensome manner.
Why Should You Attend:
This webinar will help attendees prepare for and manage an FDA inspection. The training program is integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm’s preparation and management for an FDA inspection can be done in a more effective, meaningful and easily manageable manner at all levels of an organization.At the end of the webinar, attendees will become familiar with the FDA inspection process to ensure proactively preparing for and better managing FDA inspection matters in a much less burdensome manner.
Learning Objectives:
- To be familiar with FDA inspection preparation and management
- To learn how to host an FDA inspection
Areas Covered in the Webinar:
- FDA Authority for Inspection
- Definitions
- FDA Manuals for FDA Inspection
- FDA Inspection Scope, Types and Categories
- FDA Inspection Process
- Hosting an FDA Inspection
- Answering Questions
- Responding to 483: Common Mistakes
- Dos and Don’ts Before, During and After FDA Inspection
- Misconception and Frequent Mistakes
- Recent Enforcement Cases
- Best Practices: Dos and Don’ts
- Conclusion
Who Will Benefit:
- Senior Management
- Compliance Officers
- Attorneys
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance
- R&D
- Consultants
- Contractors/Subcontractors
- Anyone Interested in the FDA (BIMO) Inspection Process
Course Provider
David Lim,
