Device Complaint Management - Webinar CD/Transcript

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Device Complaint Management: Pass Inspection Without Getting a 483

Come up short in an inspection and the FDA can issue a Form 483 or a warning letter.

But that does not have to be the case if you include the four major elements in your device complaint management system:

  • Receiving, documenting, and investigating complaints;
  • Determining when complaints are reportable to the FDA;
  • Analyzing complaints to detect recurring quality problems;
  • Updating the risk management file.

Using FDA sources such as regulations, the QSR preamble and inspection techniques, industry expert Dan O’Leary will explain each of those topics and show you how they link together while providing advice on effective implementation.

This webinar provides the practical information you need so that your device complaint management system passes an FDA inspection without a 483. In 90 minutes you will learn:

  • The definition of a complaint and issues that are not medical device complaints
  • The difference between complaint evaluation and complaint investigation
  • The conditions that require an investigation and the associated records
  • Determining reportability as an MDR
  • Linking individual complaints to the risk management file
  • Complaint analysis to determine quality problems
  • Linking complaint analysis results to the risk management file
  • Quality Assurance Managers
  • Regulatory Affairs Managers
  • Complaint Unit Managers
  • Quality Data Analysts
  • Risk Managers
  • MDR Managers and Specialists

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.