Webinar On Complaint Handling & Medical Device Reporting (MDR)
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Category Food, Drugs & Biologics
Deadline: January 16, 2015 | Date: January 16, 2015
Venue/Country: Mississauga, Canada
Updated: 2014-11-28 18:01:39 (GMT+9)
Call For Papers - CFP
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."…Your failure to establish and maintain adequate complaint handling or medical device reporting procedures…”This presentation is intended to help global medical device firms and stakeholders adequately implement US FDA-compliant medical device complaint handling and medical device reporting (MDR) systems. Even if it is believed that the similar or relevant procedures have been implemented in your firms, it is time to ensure all aspects of the requirements are under check to be adequate and compliant. To achieve compliance and to remain compliant with the FDA-compliant complaint handling and medical device reporting, it is imperative that the firms accurately understand, interpret, and implement the requirements for handling all complaints (electronic, written, or ORAL) and medical device reporting to be better sustainable as evident from a recent case. 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 SystemsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : supportcompliancetrainings.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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