2015 - Webinar On Preparing for FDA BIMO Inspection and Management

Description :
Recently, FDA inspection scope and policy have been changed and updated.
This webinar is intended to help you get familiar with FDA inspection process, in particular, Bioresearch Monitoring (BIMO) so that firms can better prepare for and manage a BIMO inspection with awareness in a proactive and effective manner.
This webinar will 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 webinar will provide great opportunities to become familiar with the FDA BIMO inspection.
The speaker will share his new and useful information to greatly improve your awareness and to consider for implementation while preparing for and managing your FDA inspection matters.
This 60-min presentation is a must for those working in FDA-regulated industries (drugs, biologics/biosimilars, medical devices including IVDs/LDTs and cosmetics, etc.).
Areas Covered in the Session :
Laws and Regulations
FDA Manuals
Inspection Guides
Hosting an FDA Inspection
Field Management Directives
Inspection Types and Categories
Inspection Classification
FDA Forms 482 and 483
Establishment Inspection Reports (EIRs)
What/How to Prepare for and Manage an FDA Inspection
How to Communicate Before, During and After inspection: Dos and Don’ts
Inspection Preparation Procedures
Close Out Meeting
Responding to 483s, If Issued
How to Communicate with Emotional Intelligence
Employee Training
Actual Case Studies
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 inspection Process