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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
Certification:
- CPD: 3 hours for your records
- Certificate of completion
Agenda
Non-Conformance and Corrective Action
- Regulatory requirements for non-conformance and corrective action
- Definitions and understanding CAPA
- Sources of non-conformance and writing an effective statement of non-compliance
- The non-conformance and corrective action cycle
- Assessment of the risk associated with non-compliance
- Root cause analysis tools and methodology
- Correction, containment and impact assessment
- Taking effective corrective action to address root causes
- Evaluation of the effectiveness of corrective action
- Use of electronic quality management systems for non-conformance management
Preventive Action
- Regulatory requirements for identification of preventive action
- Sources of preventive action and how to capture the details
- Root cause analysis
- Evaluation of the effectiveness of preventive action
Speakers
Annette Callaghan,
Sterile Management SystemsA 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
- 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
