Introduction to CAPA in Medical Devices Training

This introductory course provides a comprehensive overview of CAPA requirements, common root cause investigation tools, and the CAPA process in Medical Devices.

Our eLearning is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Introduction to CAPA in Medical Devices Training
 
Course Snapshot
Approved By
Comply Guru
Duration
6hrs
Teaching Format
eLearning
Certification of Completion
Yes
Language (s)
English

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.

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. We deploy a multi-layered methodology that offers you a New Generation of eLearning.

Not all eLearning is the same
Not all eLearning is the same
 

Course Structure Explained

Detailed Breakdown & Agenda

Our eLearning is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Time Topic
Module 1

Introduction to CAPA

  • Overview of ISO 13485:2016 and its focus on risk-based thinking.
  • Introduction to Clauses 8.5.2 (Corrective Action) and 8.5.3 (Preventive Action).
  • Key definitions: Correction, Corrective Action, and Preventive Action.

Case Study A medical device failure and the need for CAPA

Module 2

Corrective Action – Fundamentals

  • Input sources for corrective action (e.g., nonconformities, audit findings, complaints).
  • Root cause analysis techniques (Fishbone diagram, 5 Whys, etc.).
  • CAPA planning: Developing corrective action plans.

Case Study Conduct a root cause analysis using provided data

Module 3

Preventive Action – Fundamentals

  • Using risk management to identify potential issues.
  • Proactive data sources for preventive action (e.g., trend analysis)
  • Steps in implementing preventive actions.

Case Study Proactive Risk Mitigation

Module 4

Integrating CAPA with the QMS

  • Documentation requirements for CAPA (inputs, outputs, records).
  • CAPA workflows and process mapping.
  • Management reviews and CAPA effectiveness..

Case Study Identifying gaps in a CAPA process

Module 5

CAPA Process Verification and Monitoring

  • Risk management tools (e.g., risk matrix).
  • Data analytics for monitoring and measuring CAPA success.
  • Verifying CAPA effectiveness through audits and follow-ups.

Case Study Auditing CAPA effectiveness

Our Experts

Meet The People Behind The Course

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.
Leon Donnellan

Our Graphical & Instructional Designer

Leon Donnellan

Leon has over 20 years of experience in eLearning. During his illustrious career, he has spent 10+ years designing programs within highly regulated industries. He brings vast experience to Comply Guru in both graphical and instructional design.
Eoin Philip Kelly

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

Course Overview

Introduction to CAPA

What Will I Learn?

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

  • Understand & implement the Seven CAPA Steps approach.
  • Understand & meet FDA and European expectations when completing CAPAs.
  • Identify between Correction and Corrective Action.
  • Identify between Corrective Action and Preventive Action.
  • Understand Corrective Actions that address the Root Causes of failure.
  • Understand documentation needed for SMART Effectiveness Checks.
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
What Are The Entry Criteria?

Before completing this course, each Learner should have the following knowledge and/or experience:

ISO 13485

  • Must have experience of working with ISO 13485:2016 or knowledge of ISO 13485:2016

Medical Device Quality Management Systems

Knowledge of the following quality management principles and concepts:

  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices
  • The process approach used in quality management
Will I Get A Certificate?

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

How Will I Be Assessed?

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

  • Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
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 Introduction to CAPA Training

Learn about how our CAPA Training is leading the industry for innovation through online learning

 
Why Choose eLearning

Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, you will not be eligible to continue to the live workshops.
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
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.
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.

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