Medical Device CAPA and Root Cause Investigation Training

At the end of this course, Learners will have the knowledge & skills to:

• Understand & implement the Seven CAPA Steps approach.
• Understand & meet FDA and European expectations when completing CAPAs.
• Learn how to conduct thorough Investigations into the causes of failure.
• Identify between Correction and Corrective Action.
• Identify between Corrective Action and Preventive Action.
• Generate Corrective Actions that address the Root Causes of failure.
• Document SMART Effectiveness Checks criteria.
• Determine the Effectiveness of Corrective Actions.
• Determine the Overall Effectiveness of a CAPA system.

This course would be targeted at those within the MedTech Industry who are involved in any part of a CAPA system, including:

• Operators
• Technical Staff
• Managers
• Quality/Regulatory Affairs Personnel
• Engineering or Support Functions

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

In order to successfully complete this course, each Learner will need to:

• Maintain 100% attendance and
• Pass an end of course assessment

If you are completing this training virtually, the following applies:

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.