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
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
Actual FDA Inspection Case Studies (Reports)
Speaker’s PASS-IT Suggestions/Recommendations
Who will Benefit:
Research & Development
Anyone Interested in the FDA Inspection
For Live – How it works: