Description :As a domestic or foreign medical device manufacturer including an importer and user facility, you are subject to regulatory requirements for complaint handling and medical device reporting (MDR) in the US.FDA frequently cites in 483s upon establishment inspections and subsequently warning letters issued to the firms as follows.In this 60-min presentation, the speaker will guide you through the details of the required elements to successfully implement the medical device complaint handling and medical device reporting systems so that you can ensure your firms adequately establish and maintain the applicable systems in a PASS-IT manner.Areas Covered in the Session :Applicable Laws and RegulationsDefinitionsRequirements for Complaint HandlingRequirements for Medical Device ReportingApplicable Processes and ProceduresKey Elements in the Procedures: Complaint Handling and MDRWhat to Do When a Complaint Is ReceivedWhat/How/When to Investigate a ComplaintComplaints Investigation and DocumentationMedical Device ReportingHow to Determine Reportable EventsEstablishing Reportability CriteriaAdditional Documentation Requirements for MDRMistakes and How to Avoid Mistakes and 483sRelationships between Complaint Handling, MDR, and CAPAEnforcement Case StudiesImproving Our Awareness and Continuous ImprovementSpeaker’s PASS-IT suggestions and recommendationsWho Will Benefit:Complaint ManagersRegulatory AffairsQualityClinical AffairsR&D engineers and scientists, managers, directors, VPsCompliance and Legal AffairsCROAuditors and ConsultantsSenior ManagementAnyone Interested in Medical Device Complaint Handling Systems.
15 Jan 2016 @ 01:00 pm
15 Jan 2016 @ 02:00 pm
Duration: 1 hours
Timezone: GMT -5:00
Organised by Compliance Trainings (deactivated)