BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:471310
DTSTAMP:20260515T155312Z
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.\nDuring this session, we
  will evaluate the chief areas of an FDA CGMP compliance audit to see 
 actual and anticipated changes in emphasis based on this new regulator
 y climate. This information will be used to add to the FDA’s inspect
 ion “model”, to provide a field-tested approach to a company’s 
 internal audit program. QSIT for medical devices and pharmaceutical r
 equirements will be combined to provide an effective, proactive and ag
 gressive / robust internal audit program for any regulated industry. S
 oftware, data integrity, and cybersecurity issues. A suggested annual 
 time line will be presented. The “must dos” when a notice is recei
 ved of a pending FDA inspection.\nAreas Covered in the Webinar:\n\nBa
 sic U.S. FDA's expectations – the CGMPs\nThe \"target\" -- Tougher F
 DA Expectations / Requirements\nAvoid complacency from past \"good\" F
 DA / Notified Body / ISO audits\nKey medical device and pharmaceutical
  CGMP concerns\nA risk-based phased approach\nFDA “model” CGMP ins
 pections\nProve / maintain 'in control'\n\nWho Will Benefit:\n\nSenior
  and middle management.\nQuality Assurance\nRegulatory Affairs\nR&D\nE
 ngineering\n\n\nFor more information visit https://medtechiq.ning.com/
 events/structuring-and-conducting-risk-based-internal-cgmp-compliance
DTSTART;TZID=America/New_York:20220222T100000
DTEND;TZID=America/New_York:20220222T130000
CATEGORIES:webinar
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/10052918853?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR