[January 23, 2018]

Two Day Seminar: Supplier Management for Medical Device Manufacturers (Frankfurt, Germany - March 15-16, 2018) - ResearchAndMarkets.com

The "Supplier Management for Medical Device Manufacturers" conference has been added to ResearchAndMarkets.com's offering.

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management.

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. 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.

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 curse 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 suppliers' 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.

Areas Covered in the Session:

• Understand FDA QSR and ISO 13485 requirements for supplier management
• Creating a Risk-based Multi-tier supplier classification system
• Understand when suppliers have to register and list with the FDA
• Defining and using supplier Metrics
• Explain the link between design control and purchasing data
• Develop an risk-based supplier management process
  • Incorporating supplier regulatory and safety risk
  • Incorporating supplier business risk
• Create supplier measurement and monitoring systems
• Understand the how to develop and implement supplier controls
• Create a risk based Value-added system for supplier audits
• How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
• Creating acceptance criteria and understand how that fits into your supplier control process

For more information about this conference visit https://www.researchandmarkets.com/research/7868bj/two_day_seminar?w=4

View source version on businesswire.com: http://www.businesswire.com/news/home/20180123006220/en/

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