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Webinar On Preparing for FDA BIMO Inspection and Management

This webinar will provide great opportunities to become familiar with the FDA BIMO inspection.

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 RegulationsFDA ManualsInspection GuidesHosting an FDA InspectionField Management DirectivesInspection Types and CategoriesInspection ClassificationFDA Forms 482 and 483Establishment Inspection Reports (EIRs)What/How to Prepare for and Manage an FDA InspectionHow to Communicate Before, During and After inspection: Dos and Don’tsInspection Preparation ProceduresClose Out MeetingResponding to 483s, If IssuedHow to Communicate with Emotional IntelligenceEmployee TrainingActual Case StudiesConclusionWho Will Benefit:CEOsVPsCompliance OfficersAttorneysRegulatory AffairsClinical AffairsQuality AssuranceR&DConsultantsContractors/SubcontractorsAnyone Interested in the FDA inspection Process

When

24 Aug 2015 @ 01:00 pm

24 Aug 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Organised by

FutureCorp Consulting (deactivated)

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