FDA Inspection Preparation and Readiness: The Top 20 Most Common GMP Deficiencies for Device Manufacturers

$299.00

Description:

This webinar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.

The speaker will also discuss practical, actionable, and sustainable guidance on how to prepare for a sustainable FDA inspection and how to manage the FDA inspection process including Dos and Don’ts before, during and after the inspection.

This presentation will provide great opportunities to become familiar with the FDA inspection practices and the most common top twenty (20) deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.

The speaker will share his PASS-IT recommendation/suggestions.

Areas to be Covered:

Applicable Laws and Regulation
FDA Manuals and Inspection Guides
Hosting an FDA Inspection
Field Management Directives
Inspection Types and Categories
Inspection Classification
FDA Forms 482 and 483
Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device Manufacturers
How to Identify Gaps between FDA Expectations and Firms’ Current Level of Compliance
What/How to Prepare for and Manage an FDA Inspection
How to Communicate Before, During and After inspection: Dos and Don’ts
Common Mistakes and How to Prevent Them
How to Most Effectively Use Close Out Meeting
Responding to 483s, If Issued
How to Communicate with Emotional Intelligence
Employee Training
Actual FDA Inspection Case Studies (Reports)
Speaker’s PASS-IT Suggestions/Recommendations
Conclusion

Who will Benefit:

Quality Assurance
Manufacturing
Regulatory Affairs
Research & Development
Clinical Affairs
Senior Management
Consultants
Contractors
Compliance Officers
Anyone Interested in the FDA Inspection
For Live – How it works:

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.

$299.00

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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
.