Non-Conformance and Corrective Action for Medical Device Manufacturers
The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). Regulations for medical device quality management systems include particular requirements for non-conformance, correction, corrective and preventative actions. These requirements relate to non-conformances identified through internal audits, external audits, routine processes, customer complaints vigilance and many other activities. Evidence of a QMS which deals with non-conformance and prevents recurrence is important and expected when demonstrating conformity with the regulations.
These requirements are defined in ISO 13485, the international standard for medical device quality management systems, as well as in 21 CFR 820 and other global regulations.
This course provides an introduction to these regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
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Suitability - Who should attend?
Benefits of Attending
- Understand the sources of non-conformance within a medical device QMS
- Learn techniques to establish the root cause of a non-conformance
- Understand the difference between containment, correction, corrective action, and preventative action
- Gain an awareness of the ways in which an effective Corrective and Preventative Action (CAPA) system can lead to improved performance and regulatory compliance
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