This webinar is intended to help you get familiar with FDA inspection process so that it can be prepared and managed in proactive and effective manner.
This webinar discusses practical, actionable, and sustainable guidance on how to prepare for sustainable FDA inspection and how to manage the FDA inspection process including Dos and Donts before, during and after the inspection.
Areas Covered in the Session :
Applicable 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 Donts
Inspection Preparation Procedures
Close Out Meeting
Responding to 483s, If Issued
How to Communicate with Emotional Intelligence
Actual Case Studies