Corrective and Preventive Action (CAPA) – the key process in QM systems
Description
This seminar explains the basics of CAPA as set out in the EN ISO 13485 and 21 CFR Part 820.100 standards. It shows how this system can be implemented consistently during the entire product life cycle. As well as the use of CAPA subsystems and the performance of systematic data analyses, this seminar discusses the key elements of comprehensive CAPA project management. A CAPA system must always be used if deviations in processes, issues with the product or service provided, or any potential problems are expected.
In these cases, the potential cause of the error must be determined in advance in order to specify suitable measures. The aim of the correction measures is therefore to identify and rectify both errors and the causes of errors that have already occurred. Finally, it should be ensured that errors of this kind will not occur again and are not present in similar products or services.
Contact Person
Goals
This seminar explains how you can apply CAPA systematically to make improvements and how to get the most benefit from this for your business.
Seminar content
- Principles of corrective and preventive action (CAPA) from ISO 13485 and 21 CFR Part 820 (FDA)
- Differences between corrections, corrective actions and preventive actions
- Elements of a CAPA system
- Determining root causes, detection methods
- Handling deviations and customer complaints
- Classifying deviations while taking risk management into account
- Transparent planning of corrective and preventive actions
- "Root cause analysis" workshop
- Expectations for documentation
- Handling non-compliant products (separation, usage decision, risk assessment)
Target group / seminar duration and certificate
This seminar is suitable for managers who are responsible for quality and production, as well as developers and regulatory affairs staff.
The content is presented over the course of a one-day seminar. The participants receive a certificate of attendance and, on request, materials for participants in physical or digital form.
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