Good Practices in Preparing for an FDA Inspection Preparation with Awareness: Do’s and Don’ts

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Description:

This webinar is intended to help you get familiar with how to prepare for and manage an FDA inspection in an actionable, sustainable manner with improved awareness. If a firm is subject to FDA regulations, they should be ready for an FDA inspection. This webinar provides “PASS-IT” strategy and strategic plan/planning on your FDA inspection preparation integrated with emotional intelligence (EQ) skills. It is delivered in a way to help you effectively communicate and improve awareness and preparedness for an FDA inspection at all levels of organizations.

This webinar will discuss what you need to be aware and familiar with to get ready for an FDA inspection with confidence. In particular, a list of Dos and Don’ts will be shared and explained for your maximum advantages.

At the end of the webinar, you will become familiar with what and how your firm should get ready for an FDA inspection with improved awareness under your guidance.

Areas to be Covered:

Applicable Statutes and Regulations
Definitions
FDA Manuals
FDA Inspection: Scope and Depth
Inspection Types and Categories
Inspection Classification
Inspection Process
Hosting an FDA Inspection
Act with Awareness and Familiarity
Common Questions and Responding to Questions
FDA Forms 482 and 483
Responding to 483: How to Avoid Mistakes
Before, During and After FDA Inspection: Dos and Don’ts
Misconception and Mistakes – How to Avoid
Enforcement Cases
Speaker’s PASS-IT Suggestions and Recommendations
Conclusion

Who will Benefit:

CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
Research & Development Teams
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA inspection Process

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim 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, Dr. Lim 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 agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance