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 to be Covered:
Laws and Regulations
Hosting an FDA Inspection
Field Management Directives
Inspection Types and Categories
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
Actual Case Studies
Who will Benefit:
Anyone Interested in the FDA inspection Process