Medical Device CAPA and Root Cause Investigation Training that covers CAPA requirements, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.

Our training is for the MedTech Industry including those involved in any part of a CAPA system.

Why Comply Guru?

  • Highly Interactive, Engaging Experience
  • Accelerated ‘Learn By Doing’ Methodology
  • Delivered by Experts with Proven Expertise
  • Practical Exercises & Collaborative Learning
  • Tailored to your Organization

More course information is coming soon.

Course Snapshot
Accreditation
Comply Guru
Duration
16hrs
Available Format
Virtual Learning
Price
In-Company Groups

Course Overview

Medical Device CAPA and Root Cause Investigation Training

What Will I Learn?

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.
Who Should Attend?

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
Will I Get A Certificate?

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

How Will I Be Assessed?

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

  • Maintain 100% attendance and
  • Pass an end of course assessment
What Are The Technology Requirements?

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.

About our Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

 
Why Choose Instructor led Learning

Frequently Asked Questions

Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.
We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020