CAPA Requirements in Medical Devices Training
This eLearning course provides a comprehensive overview of CAPA requirements, common root cause investigation tools, and the CAPA process in Medical Devices. It can be completed Anytime, Anywhere.
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. Our online training 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.
This course is an internationally accredited credential. This is the first CAPA training course recognized by the Regulatory Affairs Professionals Society (RAPS) offering global recognition for successful learners. RAPS members will also be eligible to receive 6 credits by completing this course.
Overview of our CAPA Requirements Training
Ireland
Finland
United Kingdom
United States
What's covered on our CAPA Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- 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
- 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
- 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
- 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
- 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
Michelle Keane
Eoin Philip Kelly
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
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (6).
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:
- Complete the 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.
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Frequently Asked Questions
Each license is for 12 months. Upon completion, the module content is still accessible for the full duration. However, the assessments cannot be re-completed once successfully passed (or if you exceed 3 attempts).
Each Learner has a maximum of 3 attempts at each assessment. We strongly encourage all learners to review & revise the course content again before each attempt (if unsuccessful on an attempt).
If unsuccessful after a 3rd attempt, you will not be eligible for certification. No refunds are possible due to a failed examination result.
If you register on the website, you will be able to access the eLearning within 1 hour of registering, subject to successful payment. If you are registering via Purchase Order, access will be enabled within 1 business day of payment being received.
Yes, we offer discounts for 5 or more learners on a scale based on the total number at the time of purchase. If you want to enquire about discounts, request a quote using the form on this page and a member of our team will be in touch.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.
Please note: no certificates are available without full payment on file.
Yes, we permit substitutions provided the license has not been activated and the request is made within 30-days of the purchase date. There is no fee for substitutions.
The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic, and has been independently verified by a globally recognized professional body, i.e. CQI and IRCA, RAPS, or Exemplar Global.
In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
Extensions to the eLearning deadline (or license) are reviewed on a case by case basis. If you require an extension, please contact our team outlining your reason for the extension in advance of the expiration. Expired licenses cannot be reactivated or extended.
To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).
All graded assessments are MCQ-based.
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Training Transformed with Comply Guru
What Our Learners Are Saying
4.4
Average Rating
7 global ratings
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Over all very good and easy to follow. Good explanations for each section of the course.
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Elearning experience was excellent. Case studies, scenarios and knowledge checks were suitably detailed to really enhance the learning experience. User experience very good, course very well designed. Would not hesitate to recommend ComplyGuru courses.
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The case studies were engaging and helped bring exposure to real world concepts. The clear definitions made it easier to grasp key concepts. The explanation of different RCA techniques was excellent, very detailed and easy to follow. Its a great course with strong content, definitely recommended.
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