CAPA and root cause analysis, tools for an effective CAPA process

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Are you suffering from death by CAPA? Join this training and start breathing!

Course description

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.

Course outline

• Scope and purpose of a CAPA system
• The relationship between risk management and the CAPA system
• Selection and evaluation of data sources and data elements
• Decision on when to initiate CAPA (or not) using risk-based approach.
• Tools for root-cause-analysis
• How to plan and verify Corrective and Preventive Actions
• Effectiveness check and CAPA closure
• Documentation and communication

Learning objectives

• Review and discuss ISO 13485:2016’s and FDA’s Corrective and Preventive Action requirements.
• Managing the CAPA process, from selection of CAPA sources to detection of incidents or negative trends through root cause analysis, change control, effectiveness check and CAPA closure
• Discuss options for how to use CAPA to improve efficiency in the quality management system.
• Understand linkages in the Quality Management System between CAPA and other elements.

Who should attend

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.

Prerequisites

• Good knowledge of medical device quality management system e.g. by participating in one of our basic/intermediate trainings or equivalent knowledge from internal quality training programs.
• You should have at least 2 years of experience from the medical device industry.

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