Mastering CAPA in the Medical Device Industry

This course is built around a structured Seven CAPA Steps framework, learners will engage in hands-on practical work through a detailed case study that reinforces key concepts and simulates industry specific CAPA challenges.  

The key elements of the course are structured under the following areas of focus: 

Implementing the Seven CAPA Steps 

• Introduction to CAPA and regulatory expectations (ISO 13485 and 21 CFR 820) 
• Overview and application of the Seven CAPA Steps 
• Planning and documenting CAPA activities in alignment with compliance requirements 

Root Cause Investigation 

This section provides learners with a toolbox of techniques that can be used to effectively determine the root cause, these include Is/Is Not Analysis, Ishikawa Analysis, Concentration Diagrams, Control Charting, Cause Ranking, 5 Whys and many others.  

• Root cause investigation tools, when and how to use them 
• Documenting the Root Cause in an audit-ready format 
• Hands on Root Cause investigation case study 

Correction, Corrective Action and Preventive Action 

True corrective actions prevent recurrence of quality issues; this training enables learners to focus on prevention rather than correction or detection. 

• The differences between correction, corrective action and preventive action 
• CAPA impact assessment and containment techniques 
• How to implement true corrective actions using techniques such as Poka Yoke, potential failure analysis, standardisation and benchmarking 
• Hands on case study covering containment, risk assessment and corrective actions.   

CAPA Effectiveness 

Addressing CAPA effectiveness involves three distinct activities, learners will practice all three; 

• Validating the solution to ensure corrective actions address the original issue 
• Assessing long-term effectiveness of the corrective action 
• Monitoring the overall CAPA system to spot new or recurring problems 

Learners will partake in a hands-on case study on CAPA effectiveness assessment.   

The training involves practical exercises covering all relevant topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises.  If required, content may be tailored to reflect your organisation’s specific processes, risk profile, and regulatory setting. 

Organisations rely on diverse teams to maintain quality standards. This course equips personnel from a variety of disciplines with skills needed to implement CAPA successfully.  

The training is particularly beneficial for those involved in: 

• Quality Assurance and Regulatory Affairs 
• Manufacturing, Production or Operations 
• Engineering and Technical Support  
• Internal Auditing or Compliance Management 

A good standard of written and spoken English is important to engage effectively with this programme. 

On successful completion of the training, learners will be able to: 

• Apply the Seven CAPA Steps methodology to meet EU and FDA expectations 
• Differentiate clearly between correction, corrective action and preventive action 
• Conduct structured investigations and identify true root causes 
• Design CAPA actions that address systemic quality issues 
• Develop and implement SMART effectiveness checks 
• Evaluate both individual corrective actions and overall CAPA system performance 

These outcomes ensure that learners return to the workplace with all the practical skills they need in order to confidently complete effective CAPAs. 

This course is delivered by highly experienced tutors with specialist knowledge of medical device quality systems.  Each tutor brings a wealth of experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Learners benefit from expert-led training and direct feedback throughout the course. 

• 

  Gerry Burke

  Gerry is a self-motivated medical industry professional with kn...

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  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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To consolidate learning and reinforce key concepts, learners complete a post-course assessment.  

The assessment; 

• Checks understanding of the course content and practical scenarios 
• Assesses practical understanding and application 
• Is completed within one week of course completion 

Successful learners receive a Certificate of Achievement, in addition to their Certificate of Attendance 

Our training methodology is highly interactive, combining theory with application to build confidence and capability. Learners participate in structured discussions, case studies and applied activities throughout the programme. 

Our support includes: 

• Emphasis on hands-on application through practical exercises, case studies and group activities that reinforce key concepts and encourage active participation 
• Pre-training consultation for In-Company courses to tailor content to organisational needs 
• Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance. 
• Flexible delivery options to suit different needs: 
• Onsite or live virtual sessions tailored for teams 
• Scheduled virtual public courses for individual learners 
• Real-time support from expert Tutors 

Class sizes are generally limited to 12-15 to support personalized learning and individual support. 

Learners who complete this course often continue to deepen their skills in: 

• Technical Writing Skills for Deviations and Investigations 
• Quality Risk Management & ICH Q9 
• Process and Equipment Validation  
• MDSAP Internal Quality Auditor 
• ISO 13485:2016 & The Medical Devices Regulation (CE Marking Process)