Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems


David R. Dills, Regulatory Affairs & Compliance Consultant is a Keynote Speaker at ComplianceKey provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 24 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized........

Overview

An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing. As users and regulatory agencies are becoming less 'tolerant' of medical device failure, regulatory agencies are placing greater emphasis on postmarket surveillance as a way to improve risk management and protect public health. 
Written procedures for complaint handling will ensure that all complaints are reviewed in a timely and uniform manner. A complaint log or complaint file is required and should be updated whenever necessary. Basic information for the file includes but is not limited to the name of the device, date the complaint was received, complainant name and address, nature and details of the complaint, and the device identification/control number. When reviewing a complaint, be sure to determine whether any additional investigation is necessary. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications should be investigated further. Pay special attention to whether the complaint triggers any reporting requirements under FDA and EU regulations. If the complaint triggers a Medical Device Report (MDR), ensure that the complaint file is clearly identified or maintained separately from other complaint files.
The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution. The regulatory expectations for medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Common FDA observations are inadequate procedures or not following procedures for receiving, reviewing, and evaluating complaints; failure to close out complaints in a timely manner; and a disconnect between complaints with adverse events and MDR requirements. We will address this and much more, including relationships with postmarketing surveillance and complaint handling, requirements and effective strategies for surveillance and complaint handling, reportable events, escalation, timelines, and more.

Why should you attend this webinar?

Areas Covered in the Session:

Who can Benefit:

All levels of Management for all departments and those who desire a better understanding and overview of the postmarket complaint handling activities from intake or receipt, processing and investigation, trending, close-out and reporting requirements for FDA and EU, including:
  • Complaint Handling Unit
  • Complaint Analyst
  • QA/QC/Compliance/Regulatory Affairs
  • Marketing & Sales & Customer Service
  • Quality Engineering
  • Field Service
  • Engineering/Technical Services
  • Consultants 
  • Operations and Manufacturing
 



Webinar Id: LHSCDRD001

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Duration: 60 mins

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 $167 (Single Attendee)  $599 (Unlimited Attendee)

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