Product Recalls Training

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 course, each Learner will need to:

• Complete all eLearning 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.