Global
Ireland
Finland
United Kingdom
United StatesCAPA Practitioner for Medical Devices Training
CAPA Practitioner for Medical Devices 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.
Our blended learning course is a hybrid approach where you first complete 6hrs of eLearning modules on the underlying theory that better prepares you in advance of attending a 1-day Live Workshop with an Instructor that focus on practical application in a real life context.
This course recognized by the Regulatory Affairs Professionals Society (RAPS) offering global recognition for successful learners. RAPS members will also be eligible to receive 12 credits by completing this course.
Overview of our CAPA Training for Medical Devices
Upcoming Dates for CAPA Training for Medical Devices
Register 3 + Get 1 Free
What's covered on our CAPA Practitioner Training
Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.
- 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
eLearning Recap
Practical Workshop Identifying the Problem (Problem Statement – Scenarios), continued.
Practical Workshop Evaluating the Risk and Impact, Determining the Plan to Investigate and Investigating the Problem and determining its Cause
Practical Workshop Create an Action Plan and Implement CAPA Action Plan
Practical Workshop Verify Effectiveness and CAPA Process Steps
RCA Methodologies Introduction
Practical Workshop 5 Whys, 8D Root Cause Analysis, Cause & Effect, Pareto Chart
Practical Workshop Root Cause Analysis (5 whys, Fishbone, 8D)
Michelle Keane
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
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 (12).
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 assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for (applies to blended format only)
- Fully attend the Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
For the live workshops during a virtual delivery, we utilize Microsoft Teams and SharePoint.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the 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.
Need Corporate, In-House or Customized Training?
Comply Guru offers corporate, in-house and customized training solutions for your organization’s specific needs.
Speak with an experienced member of our team today to learn how we can help.
Frequently Asked Questions
Blended Learning is Better Learning
Training Transformed with Comply Guru
What Our Learners Are Saying
4.6
Average Rating
114 global ratings
-
Overall very good interactive course. Will apply this learning in the workplace over the coming weeks.
-
Both learning online and in house were very helpful and effective, instructor very knowledgeable and comfortable to learn from, overall excellent.
-
Very enjoyable course. Now I have a better understanding of the topic and will use this knowledge at work when doing CAPA.
-
Very important EHSQ topic, delivered very effectively.
-
Gained a lot of knowledge during the course, very informative and looking forward to using it practically in my role
Related Training Courses
