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United StatesIntroduction 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.
Completion
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
Case Study A medical device failure and the need for CAPA |
| Module 2 | Corrective Action – Fundamentals
Case Study Conduct a root cause analysis using provided data |
| Module 3 | Preventive Action – Fundamentals
Case Study Proactive Risk Mitigation |
| Module 4 | Integrating CAPA with the QMS
Case Study Identifying gaps in a CAPA process |
| Module 5 | CAPA Process Verification and Monitoring
Case Study Auditing CAPA effectiveness |
Course Overview
Introduction to CAPA
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.
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
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
Successful completion will entitle each Learner to receive a digital Certificate of Achievement within 1 business day.
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)
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.
Why Choose Comply Guru
About our Introduction to CAPA Training
Learn about how our CAPA Training is leading the industry for innovation through online learning
