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How do you implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDR's, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Industry experts and FDA staff will explore these issues during this day and a half workshop.
Agenda Topics Include:
- Complaints: Definitional questions
- Setting up a complaint system
- Handling complaints & trending
- Recalls and other field actions
- Understanding MDRs
- An introduction to Health Hazard Evaluation (HHE)
- Reporting and products liability
- Part 806 reports of removals and corrections
- Current FDA inspection and enforcement trends
- Measuring the effectiveness of your complaint system
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