Mississauga Canada
January 21, 2014
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Description :

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 Don’ts before, during and after the inspection.

Areas Covered in the Session :

Applicable 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



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Compliance Trainings