CAPA is a critical part of a company’s quality system. Failure to have a robust CAPA system can be costly for a company. If you are having problems with your CAPA system download this FREE eBook to learn how to deal with a problematic CAPA system.
1 Day
These courses will run from 9.30am - 4.30pm (IST/UTC+1).
Instructor - led virtual training.
€345
A certificate of completion will be issued on successful course completion.
Basic (A very basic knowledge of the topic but no professional usage).
Each participant will receive a training manual
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
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.
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We also offer elearning and in-company CAPA courses.
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