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UID:2140535:Event:471185
DTSTAMP:20260515T215823Z
SUMMARY:Structuring and Conducting Risk-Based Internal cGMP Compliance
  Audits
DESCRIPTION:This training will evaluate the chief areas of an FDA cGMP
  compliance audit and help you understand the actual and anticipated c
 hanges in emphasis based on this new regulatory climate. It will prepa
 re you and your company for tougher US FDA cGMP compliance audits.\n\n
 Why Should You Attend:\nThere is an on-going major shift in the emphas
 is of U.S. FDA CGMP compliance inspections (audits). These changes in 
 focus have a major impact on individual compliance objectives, efforts
  and measurements of success.\nAnd business continues to \"shoot itsel
 f in the foot\", including once highly respected companies. All this a
 ffects the Agency's approach to audits and their expectations for comp
 anies. They also use GMP compliance audits to drive companies to do mu
 ch of their work for them. Failure to anticipate, find and correct com
 pliance problems before an FDA site inspection can result in unnecessa
 ry 483 Observations, possible Warning Letters, or worst, and a competi
 tive “hit” in the marketplace – all preventable by the effective
  internal CGMP compliance audit / inspection.\n\nAreas Covered in the 
 Webinar:\n\nBasic U.S. FDA's expectations – the CGMPs\nThe \"target\
 " -- Tougher FDA Expectations / Requirements\nAvoid complacency from p
 ast \"good\" FDA / Notified Body / ISO audits\nKey medical device and 
 pharmaceutical CGMP concerns\nA risk-based phased approach\nFDA “mod
 el” CGMP inspections\nProve / maintain 'in control'\nFight “entrop
 y”\n\nWho Will Benefit:\n\nSenior and middle management.\nQuality As
 surance\nRegulatory Affairs\nR&D\nEngineering\nStaff and Line personne
 l\nSales and Marketing\nOperations / Production\n\n\nFor more informat
 ion visit https://medtechiq.ning.com/events/structuring-and-conducting
 -risk-based-internal-cgmp-compliance-1
DTSTART;TZID=America/New_York:20220222T100000
DTEND;TZID=America/New_York:20220222T130000
CATEGORIES:pharma
LOCATION:online
WEBSITE:https://www.complianceonline.com/us-fda-cgmp-compliance-audits
 -webinar-training-701432-prdw?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/us-fda-cgmp-compliance-audits-web
 inar-training-701432-prdw?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10052920460?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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