How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices

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

Instructor Profile:

Dr. David Lim, Ph.D., RAC, ASQ-CQA, is president and principal of Regulatory Doctor. He frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, he developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agencies (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. He contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. He serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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