Device Complaint Management - Webinar CD/Transcript
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