Recall Management for Devicemakers


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:

  • What’s the difference between a “stock recovery” and a “market withdrawal” and which does the agency consider a recall?
  • Is a design change to a device a “product enhancement” or a problem correction?
  • What does the FDA consider a “risk to health” and how do you determine if your recall falls into that category?

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:

  • Key definitions in FDA recall regulations, such as correction, removal, market withdrawal, stock recovery and how the agency interprets them
  • How to decide whether to issue a recall and the documentation needed to justify the decision to the FDA
  • What distinguishes a product enhancement from a recall
  • The differences between recall regulations in CFR Part 7 and CFR Part 806
  • How the FDA defines “risk to health”
  • The consequences of noncompliance

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:

  • Trainees can take the course individually and in their own time, at their own desk.
  • 5-question assessment reinforces lessons learned and allows trainees to demonstrate their understanding of the material.
  • SCORM-compliant software calculates individual’s scores and reports results.
  • Trainers can incorporate the eLearning program into their Learning Management Systems to track trainees’ progress and overall success rates.
  • Can be used by many trainees at the same time if loaded on a network or as a stand-alone course for use by individuals one at a time.
  • Includes original source files, so trainers experienced in Storyline 2 eLearning development software can customize the program to fit their needs.

Order Your Copy Today!

Product Details
when Price: $257
when Time: 10 minutes

(Add $10 shipping and handling per item shipped to the US or $35 per item shipped elsewhere. VA residents, please add 6 percent sales tax.)

Click here for the eLearning Product Specs.

Who Will Benefit

Anyone responsible for:

  • Regulatory affairs/compliance
  • Quality assurance
  • Sales and marketing
  • Customer service

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Your risk is zero when you purchase under our money-back guarantee. Not satisfied with this product return it within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling).