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

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 Covered in the Session :
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
Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
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https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1511
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