A Corrective and Preventative Action (CAPA) process is one of the most important components of any medical device company’s Quality Management System (QMS). CAPA is a system/process of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of the nonconformity. The objective of a CAPA process is to ensure that if a problem occurs, that it is investigated in such a way, that the corrective actions that are put in place will ensure that the problem will never occur again.

In this course participants will learn about the fundamentals of a medical device CAPA process. This training will also help participants understand the CAPA requirements in 21 CFR 820 (FDA) and ISO 13485: 2016.

On completion of this training, participants will be able to:

• Understand the ISO 13485 CAPA and 21 CFR 820 and requirements
• Understand the steps in a CAPA process
• Distinguish between correction and corrective action
• Distinguish between corrective action and preventive action
• Write a problem statement
• Conduct thorough investigations into problems and determine their root cause(s)
• Use the 5 Whys problem-solving technique
• Use the fishbone diagram cause-and-effect technique
• Implement corrective actions
• Determine the effectiveness of corrective actions
• Disseminate information about CAPAs to relevant personnel in the organisation
• Learn the importance of the CAPA system to the organisation (internal and external audit)
• Locate FDA warning letters that document CAPA non-conformances

• Personnell assigned to investigate problems and work on CAPAs
• Individuals who are new to the medical device industry and require an introduction to CAPA
• Companies who must remediate their CAPA processes due to regulatory findings (including warning letters) who wish to embed CAPA fundamentals in their teams
• Internal auditors
• Supplier auditors
• Quality engineers
• Managers wanting to learn how a CAPA process works

Dr. Fiona Masterson

With over 25 years’ experience in quality management, operations management, and higher education, Fiona combines technical expertise with highly engaging training. She has worked in fast-paced manufacturing environments including medical device companies, and lectures part-time in universities.

She is a lead quality auditor and managed the CAPA programme of a leading medical device company. She lead a project to remediate a medical device company’s CAPA process in response to a FDA consent decree.

She has Bachelor and Master of Science degrees, and a Doctorate in Mechanical Engineering. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.