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FDA Inspection Master Class
Introduction
Welcome and Course Overview
Meet the Instructor, DeVaughn Edwards
Importance of FDA Inspections in the Pharmaceutical Industry
Understanding FDA Inspections
Overview of FDA Inspection Process
Inspection Focus Areas and Common Pitfalls
Regulations and Guidelines for FDA Inspections
FDA Masterclass Video (44:03)
Preparation for FDA Inspections
Preparing for an FDA Inspection
Role of Different Departments in Inspection Preparedness
Documentation and Record-Keeping Best Practices
During the FDA Inspection
Managing the Inspection Process Effectively
Interacting with FDA Inspectors
Handling Unexpected Situations During Inspections
Post-Inspection Response
Understanding FDA Form 483 and Response Strategies
Corrective and Preventive Action (CAPA) Plans
Case Studies and Real-World Examples
Success Stories of Companies in FDA Inspections
Lessons Learned from Companies with Inspection Failures
Staying Ahead of FDA Expectations
Trends in FDA Inspections and Regulatory Changes
Conclusion
Certificate of Completion Submission Instructions
Regulations and Guidelines for FDA Inspections
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