This course proposes methods for managing and controlling suppliers based on the requirements of the MDD, AIMDD, IVDD, ISO 13485, 21 CFR 820 and guidance from the GHTF (IMDRF). The relevant definitions are clarified while placing the importance of supplier qualification within the regulatory framework, and going further into detail about the identification of critical suppliers, the development of contractual aspects, the control of supplier activities and the handling of non-conformities, before concluding with a list of critical inputs for supplier audit plans.
Upon completion of this course, trainees will be able to correctly and successfully:
- Set up a supplier qualification system
- Implement methods for effective supplier control within the quality system
- Develop critical tools for supplier audits.
Supply chain and purchasing managers, quality managers, regulatory affairs managers, production managers, design and development managers, and clinical quality managers involved in defining, selecting and qualifying and overseeing suppliers.
In order to fully benefit from this course, we recommend familiarity with “SG3/N17:2008 Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers” and knowledge of the subjects discussed in the following WMDO courses:
- ISO 13485: Foundation and Basic Principles (ID 196)
- Overview of US FDA Quality System Regulation (ID 118)
- Risk Management for Medical Devices in the EU and US (ID 77)
- The Design, Development and Industrialization of Medical Devices (ID 183)
- For clinical professionals, understanding resource management as discussed in clinical project manager (ID 100) is a critical combination to improve skills