2014 - Preparing for FDA BIMO Inspection and Management

Instructor: David Lim
Description:
This webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance 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 asnd management program will also be discussed.
At the end of the webinar, you will be presented with ample information to drastically improve your current FDA inspection readiness program or equivalent with awareness and confidence.
Objectives of the Presentation:
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
Exercising Sound Judgment
Good Business and Employment Practices
Transparency, Accountability and Integrity
Practical, Actionable and Sustainable Recommendations: Best Practices
Conclusion
Who can 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
http://www.onlinecompliancepanel.com/ecommerce/web...
Online Compliance Panel LLC.
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California 94536, USA
Call: +1-510-857-5896