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UID:2140535:Event:64676
DTSTAMP:20260522T154522Z
SUMMARY:Webinar On Establishing a Robust Complaint Management System
DESCRIPTION:Lack of an effective complaint management system is one of
  the more frequent Form 483 observations cited during FDA device estab
 lishment inspections. In fact, failure to process complaints in a time
 ly and uniform manner will quickly lead to other Quality Management Sy
 stem issues such as late Medical Device Reports (MDRs) or the potentia
 l to completely miss an opportunity to file an MDR for a serious adver
 se event.\nIf your organization is struggling with an overly burdensom
 e complaint management system or the number of complaints is continuin
 g to rise with no end in sight, then now would be a good opportunity t
 o streamline your organization’s approach to complaint management.\n
 This Webinar will breakdown the complaint management process so attend
 ees will be exposed to a clear, concise and compliant approach to comp
 laint management in accordance with 21 CFR, Part 820.198 requirements.
  Remember, there are no such things as maximum compliance or minimum c
 ompliance; there is just compliance when it comes to meeting the FDAâ€
 ™s requirements for the complaint management system.\nAreas Covered in
  the Session :\nReviewing the Requirements Associated with 21 CFR, Par
 t 820.198\nUnderstanding the agency’s interpretation of processing c
 omplaints in a timely and uniform manner.\nInformation that needs to b
 e incorporated into a complaint file.\nThe complaint investigative pro
 cess.\nProcessing oral complaints.\nUse of decision trees to determine
  the need to report a complaint as an MDR reportable event.\nThe docum
 entation process for when a decision is made not to investigate a comp
 laint.\nCustomer response letters and follow-up.\nLinkage to the CAPA 
 System\nWho Will Benefit:\nQuality Professionals\nRegulatory Professio
 nals\nCustomer Service Professionals\nMedical Science Professionals\nP
 rice Tags:\nLive\nSingle Live : For One Participant\n$ 249\nCorporate 
 Live : For Max. 10 Participants\n$ 899\nRecording\nSingle REC : For On
 e Participant - Unlimited Access for 6 Months\n$ 299\nFor more informa
 tion and enquiries contact us at\nCompliance Trainings\n5939 Candlebro
 ok Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915
 -4458  Email : support@compliancetrainings.com\nFor more information
  about this event please visit\nhttps://compliancetrainings.com/SiteEn
 gine/ProductDetailView.aspx?id=MD1440\n\nFor more information visit ht
 tps://medtechiq.ning.com/events/webinar-on-establishing-a-robust-compl
 aint-management-system
DTSTART;TZID=America/New_York:20141120T130000
DTEND;TZID=America/New_York:20141120T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1440
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1440
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011741?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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