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Non-Conformance and CAPA for Medical Device Manufacturers: ISO 13485 Compliance
17 February 2026 | Short Online Course
Original price was: $467.$374Current price is: $374.
1-Day Live Online training | Gain the skills to manage non-conformance and corrective actions — ensuring compliance, audit readiness, and continual improvement.
Learn more about the course by toggling through the tabs below.
Course Overview
Effective management of non-conformance and corrective action (CAPA) is vital to maintaining compliance with ISO 13485 and ensuring product safety and quality. Failures in CAPA systems are among the most common findings during audits and inspections, often leading to non-conformities, recalls, or enforcement actions.
This practical course provides an essential guide to identifying, recording, investigating, and resolving non-conformances within a medical device Quality Management System (QMS). Participants will learn how to apply root cause analysis tools, determine appropriate corrective actions, verify their effectiveness, and prepare for regulatory audits. Real-world examples and exercises will help reinforce best practices for compliance and continuous improvement.
Key Learning Objectives
- Understand ISO 13485:2016 requirements for non-conformance and CAPA.
- Identify different sources and types of non-conformance in manufacturing and quality systems.
- Apply the full non-conformance and corrective action cycle: detection, investigation, correction, corrective action, and verification.
- Use practical root cause analysis tools such as 5 Whys, Fishbone diagrams, and FMEA.
- Implement containment and risk-based corrective actions.
- Record and track CAPA activities effectively using logs and templates.
- Demonstrate compliance during internal and external audits.
Who Should Attend?
This course is ideal for professionals working within medical device and IVD organisations, including:
- Quality Assurance and Regulatory Affairs professionals
- Manufacturing, Operations, and Production Managers
- Internal Auditors and Compliance Officers
- CAPA Coordinators and QMS Leads
- Anyone responsible for non-conformance management, root cause analysis, or audit preparation
Course Outline
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
17 February 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
Introduction to Non-Conformance and CAPA in ISO 13485
- Understanding the regulatory importance of non-conformance and corrective action
- ISO 13485:2016 requirements and key terminology
- Definitions: non-conformance, correction, corrective action, preventive action
- The role of risk management (ISO 14971) in CAPA systems
Identifying and Recording Non-Conformances
- Sources: internal audits, supplier audits, customer complaints, production deviations
- How to write clear, factual non-conformance reports
- Containment and correction actions: stopping the problem before escalation
- Documenting non-conformances effectively
Session 2
120 mins | 10:00 AM UK
Root Cause Analysis and Corrective Action Planning
- Recording and documenting non-conformances
- Common tools: 5 Whys, Fishbone Diagram, Pareto analysis, and FMEA
- Determining true root cause vs. symptom correction
- Developing SMART corrective actions and assigning responsibilities
- Verification of effectiveness: measuring impact and preventing recurrence
Monitoring, Trending, and Audit Readiness
- Maintaining CAPA logs, metrics, and dashboards
- Trending and analysing non-conformance data to identify systemic issues
- Preparing CAPA evidence for audits and inspections
- Common pitfalls and examples of CAPA-related audit findings
Wrap-Up & Q&A
- Summary of best practices for a robust CAPA process
- Practical tips for ensuring continual improvement and compliance
Annette Callaghan is a quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
17 February 2026
1-Day Live Online Training
Register at the top of the page.
Course Times
For live online delivery, the course starts at 10:00 AM (UK time) and finishes at 3:00 PM (UK time).
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to 2 weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
Live Online
This course is delivered live online with direct access to the trainer.
4 Hours of Learning
This course includes a total of 4 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
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