Are you suffering from death by CAPA? Join this training and start breathing!
This course provides you with a full understanding of the MDSAP requirements place on a Quality Management System, and the relationship between MDSAP, ISO13485:2016 and corresponding regulatory requirements.
This course will help you understand how to interpret the Corrective and Preventive Action requirements in ISO 13485:2016 and the US Food & Drug Administration’s Quality System Regulation. Through exercises and real-world examples, you will learn how to improve your CAPA process, from CAPA sources and preventive actions through root cause analysis, action plans and effectiveness check.
You will understand how to establish a compliant Corrective Action and Preventive Action (CAPA) process and how to make use of existing guidance and industry best practices to transform your CAPA process from a “must-do” to a tool for risk management and sustainable improvement.
Examples from both general Medical Devices and In-Vitro Diagnostic products and processes will be used in the training, to ensure it is suitable for anyone in the medical device industry, regardless of product category.
The course is suitable for persons involved in, or responsible for the operation or audit of a Quality Management System for medical devices working with planning, performance and monitoring of CAPA actions and the CAPA system.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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