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Webinar On Preparing for FDA BIMO Inspection and Management

Event Details

Webinar On Preparing for FDA BIMO Inspection and Management

Time: August 24, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Aug 7, 2015

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Event Description

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

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