Simplifying Global Compliance
Recall Management for Devicemakers
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One of a devicemaker’s biggest headaches is handling a recall. Aside from the logistical nightmare, there are the FDA’s expectations to deal with. Conflicting regulations in Parts 7 and 806 make it hard to understand when you must report a recall and when reporting is voluntary. And the terminology the FDA uses presents some headscratchers, for instance:
Trouble identifying whether a change to a device meets the definition of a recall can result in inconsistent interpretation of regulations, uncertainty in your regulatory responsibility and delays between the times that a device defect or failure is identified and the time that the public is notified. Think about all the people in your organization who play a role in the recall process. Do they understand all the regulations? Do they know what the FDA considers a recall? Do they understand the potential consequences of ignoring the rules? Do they know how to report a recall and when they don’t have to? In just 10 minutes, noted recall management specialist, Pamela Furman Forest can ease your fears by teaching your employees all they need to know about dealing with device recalls, including:
In addition FDA recall chief Ron Brown weighs in on how the agency looks at recalls and what it wants to see from devicemakers. And the 5-question assessment at the end of the course verifies trainees’ understanding of the material. Additional benefits:
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