DUBLIN, November 4, 2016 /PRNewswire/ -- Research and Markets has announced the addition of the "Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar" conference to their offering.
Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. - How well do you understand the requirements for supplier management? - Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the supplier's location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. In addition to the discussion material, the course includes multiple exercises, guidance documents, and templates/tools to help you implement an effective program. Learning Objective: Upon course completion, participants will: - Understand FDA QSR and ISO 13485 requirements for supplier management - Understand the FDA's multi-tier supplier classification system