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TZID:America/New_York
X-LIC-LOCATION:America/New_York
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TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
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DTSTART:19701101T020000
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BEGIN:VEVENT
UID:2140535:Event:67515
DTSTAMP:20260413T081404Z
SUMMARY:Webinar On Complaint Handling Requirements - Interrelationship
  with CAPA, Change Control, Adverse Event Reporting and Recalls, Life 
 Cycle Process Activities
DESCRIPTION:Description :\nThis webinar will provide the regulatory re
 quirements (US) for complaint handling in the Medical Device and Pharm
 aceutical industries. The session will include requirements for compla
 int files and key requirements of:\nComplaint Procedures\nInvestigatio
 ns\nWhat to document when it is determined that an investigation is no
 t needed\nWhat actions are required if a complaint represents a report
 able event\nRecord retention\nThe course will touch on complaint sourc
 es, and details will be furnished on the interrelationships regarding 
 Complaint Handling/Change Control/Adverse Event Reporting/and Recalls.
  The course will also include timeline requirements associated to adve
 rse event reporting, which reporting formats to use, when to recall an
 d types of recalls.\nIn addition, the webinar will incorporate the Com
 plaint Handling Life-Cycle Process and an example of activities involv
 ed in this life cycle. Furthermore, this webinar will discuss complain
 t handling implementation challenges, in addition to pitfall challenge
 s. At the end of this webinar, there will be a conclusion section, whe
 re points to take into account with the integration of CAPA/Change Con
 trol/Adverse Event Reporting/Recalls/Complaint Files in the Complaint 
 Handling Life-cycle, will be detailed.\nAreas Covered in the Session :
 \nComplaint Definition and Sources\nMedical Device and Drug Complaint 
 Handling Requirements (US)\nInterrelationship of  Complaint Handling,
  CAPA, Change Control, Adverse Event Reporting and Recalls\nReportable
  Events\nWhen Does a Complaint Become a Reportable Adverse Event\nWhat
  in Itself is a Reportable Event\nHow Does User Error Relate to Advers
 e Event Reporting\nVoluntary and Mandatory Reports, and Reporting Time
 lines\nComplaint Handling Life-Cycle Process (including an example tha
 t embraces activities related to above five bullet points)\nWhat May T
 rigger a Recall During the Complaint Investigation\nRecall Classificat
 ions\nChallenges\nConclusion\nReferences\nWho Will Benefit:\nRegulator
 y Compliance Professionals\nQuality Assurance Professionals\nQuality C
 ontrol Professionals\nRegulatory Affairs Professionals\nComplaint Hand
 ling Professionals\nQuality Engineers\nService Technicians and Enginee
 rs\nManufacturing and Design Engineers\nProcess Development Personnel\
 nCustomer Service Personnel\nSales Representatives\n\nFor more informa
 tion visit https://medtechiq.ning.com/events/webinar-on-complaint-hand
 ling-requirements-interrelationship-with
DTSTART;TZID=America/New_York:20151215T130000
DTEND;TZID=America/New_York:20151215T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1710
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1710
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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