Product Recalls Training
This course provides an introduction to Product Recalls in the medical device industry, with a focus on FDA requirements under 21 CFR Part 7 and Part 806.
You’ll learn hat a recall is, how recalls are classified, and the steps involved in executing a recall. The course also covers employee responsibilities, the importance of timely communication, and how recalls protect patient safety and ensure regulatory compliance.
Our eLearning is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Overview of our Product Recalls Training
What's covered on our Product Recalls Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
Michelle Keane
Eoin Philip Kelly
At the end of this short course, successful learners will be able to:
- Define what a recall is under FDA Regulations
- Explain the FDA’s recall classification system (Class I, II, III)
- Describe the regulatory requirements for Medical Device Recalls under 21 CFR Part 7 & 806
- Outline the recall process, from detection to correction and closure
- Recognize their role in identifying, reporting, and supporting recall activities
This course is for individuals or organizations who want to understand Product Recalls in the Medical Device Industry (with FDA Focus)
Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.
In order to successfully complete this eLearning course, each Learner will need to:
- Complete the eLearning course modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Have 5 or more that need training?
We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.
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