Presented by
Management Forum
Non-Conformance and Corrective Action for Medical Device Manufacturers Training Course
An Essential Introduction
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). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.
7 December 2023
from £299
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
- Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
- UK Conformity Assessed (UKCA) Marking for Medical Devices
- Sterilization of Medical Devices
- An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
- Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
- Non-Conformance and Corrective Action for Medical Device Manufacturers
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.
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
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 - https://www.iso.org/standard/59752.html
This standard is also available from national standards organisations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.
The Non-Conformance and Corrective Action for Medical Device Manufacturers course will cover:
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
Non-conformance and Corrective Action (continued)
- 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
Annette Callaghan
Sterile Management Systems
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).
Book Non-Conformance and Corrective Action for Medical Device Manufacturers Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
7 December 2023
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14241
- GBP 299 349
- EUR 429 499
- USD 501 579
Until 02 Nov
- 3 hours of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
