2014 - Implementing the Best Practices for FDA Inspection Preparation and Management

DESCRIPTION
This webinar is intended to help you get familiar with how to implement 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 the inspection 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 drastically 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
Regulatory Requirements for Compliance
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
Practical, Actionable and Sustainable Recommendations: Best Practices
Conclusion
Who will benefit: (Titles)
CEOs
VPs
Compliance Officers
Attorneys
Regulatory Affairs
Clinical Affairs
Quality Assurance
R&D
Consultants
Contractors/Subcontractors
Anyone Interested in the FDA (BIMO) Inspection Process
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance