Dr. David Lim

Speaker: Dr. David Lim

Webinar Code: OCH 100 405

Webinar Duration: 60(Minutes)

Best Practices for FDA Inspection Preparation and Management

Webinar Date: Friday 27th of September 2019 10:00 AM PDT | 01:00 PM EDT
Available Options
$195.00
{ For One participant }


$250.00
{ Unlimited Access for Six months }


$375.00
{ Live + Recorded webinar }


$550.00
{ Live Access for 10 Participants }



Qty:  

This webinar is intended to help you get familiar with the best practices for FDA inspection preparation and management integrated with emotional intelligence (EQ) so that a firm’s preparation and readiness for an FDA (BIMO) inspection can be done in a more effective, less burdensome, and easily manageable manner at all levels of organization. 

This webinar will discuss what you need to be aware and become familiar with for your job to get done easier and in a less burdensome, straight-forward manner.  The best practices for FDA BIMO inspection preparation and readiness purposes including a list of Dos and Don’ts before, during and after FDA inspections will be discussed.  In addition, some key factors contributing to the overall efficiency and effectiveness of your FDA inspection readiness and management program will also be discussed. 

At the end of the webinar, you can have a great opportunity to significantly improve your current FDA inspection preparation and readiness program or equivalent with awareness and confidence.

Areas Covered in the Session

  • Statutes and Regulations
  • Definitions
  • FDA Manuals
  • FDA (BIMO) Inspection: Scope and Depth
  • Inspection Types and Categories
  • Inspection Classification
  • Inspection Process
  • Hosting an FDA Inspection
  • How to Answer Questions
  • FDA Forms 482 and 483
  • Dos and Don’ts Before, During and After FDA Inspection
  • Responding to 483:  Best Practices
  • Misconception and Frequent Mistakes
  • Enforcement Cases
  • Improving Awareness and Exercising Sound Judgment
  • Good Business and Employment Practices
  • Transparency, Accountability and Integrity
  • PASS - IT Recommendations: Best Practices
  • Conclusion

 

Who will benefit: 

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA (BIMO) Inspection Process