Course Overview
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.
CPD Hours: 3
Course Content
- Day 1
- Non-Conformance and Corrective Action
- Non-conformance and Corrective Action (continued)
- Preventive Action
Speakers
Annette Callaghan
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Who Should Attend
Who Should Attend
- Managers and supervisors working within a regulated Quality Management System (QMS)
- Regulatory Compliance specialists
- Quality Management System (QMS) specialists
- Internal Auditors
- Regulatory and Quality professionals
Please note that access to a copy of ISO 13485 would be beneficial to delegates attending this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:
ISO 13485 - [external URL]
This standard is also available from national standards organisations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
