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UID:2140535:Event:66535
DTSTAMP:20260530T163147Z
SUMMARY:Webinar On Preparing for FDA BIMO Inspection and Management
DESCRIPTION:Description :\nRecently, FDA inspection scope and policy h
 ave been changed and updated.\nThis webinar is intended to help you ge
 t familiar with FDA inspection process, in particular, Bioresearch Mon
 itoring (BIMO) so that firms can better prepare for and manage a BIMO 
 inspection with awareness in a proactive and effective manner.\nThis w
 ebinar 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.  \nThis webinar will provide great opportuniti
 es to become familiar with the FDA BIMO inspection. \nThe speaker wil
 l share his new and useful information to greatly improve your awarene
 ss and to consider for implementation while preparing for and managing
  your FDA inspection matters. \nThis 60-min presentation is a must fo
 r those working in FDA-regulated industries (drugs, biologics/biosimil
 ars, medical devices including IVDs/LDTs and cosmetics, etc.).\nAreas 
 Covered in the Session :\nLaws and Regulations\nFDA Manuals\nInspectio
 n Guides\nHosting an FDA Inspection\nField Management Directives\nInsp
 ection Types and Categories\nInspection Classification\nFDA Forms 482 
 and 483\nEstablishment Inspection Reports (EIRs)\nWhat/How to Prepare 
 for and Manage an FDA Inspection\nHow to Communicate Before, During an
 d After inspection: Dos and Don’ts\nInspection Preparation Procedure
 s\nClose Out Meeting\nResponding to 483s, If Issued\nHow to Communicat
 e with Emotional Intelligence\nEmployee Training\nActual Case Studies\
 nConclusion\nWho Will Benefit:\nCEOs\nVPs\nCompliance Officers\nAttorn
 eys\nRegulatory Affairs\nClinical Affairs\nQuality Assurance\nR&D\nCon
 sultants\nContractors/Subcontractors\nAnyone Interested in the FDA ins
 pection Process\n\nFor more information visit https://medtechiq.ning.c
 om/events/webinar-on-preparing-for-fda-bimo-inspection-and-management
DTSTART;TZID=America/New_York:20150824T130000
DTEND;TZID=America/New_York:20150824T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1681
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1681
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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