Why You Should Attend:
The FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. In February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers. This guidance document has become the global de facto standard for supplier management. The seminar helps you understand the regulations and the expectations of the guidance document along with discussion on the six general principles from the GHTF guidance document and implement methods based on these principles.
Supply chains for medical devices are important now and growing in importance as device manufacturers outsource products and services low cost destinations it is becoming longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function. As part of their Quality Management System (QMS) requirements, manufacturers must evaluate, select, and monitor suppliers.
This Medical device supply chain seminar explains the regulations and helps you implement the GHTF guidance document. The team approach, often called a commodity team or supplier team, is one of the most effective methods for supplier selection and management. The team needs to understand the requirements, implement the best practices in the GHTF document, and work with suppliers.
This Supplier Quality seminar provides the tools and techniques to help your teams manage the supplier base. You will learn both the requirements for managing suppliers and the reasons for these requirements. We explain the requirements of the FDA’s Quality system Regulation (QSR). In addition, we also look at the FDA’s preamble to the 1996 regulations. The preamble offers information about the regulation and the expectations.
For products subject to the EU directives on medical devices, manufacturers must implement ISO 13485 as a harmonized standard. The seminar explains the requirements in this standard, but also covers the related information in the associated technical report. ISO/TR 14969:2004, entitled Medical devices – Quality management systems – Guidance on the application of ISO 13485:2003, explains the standard. It provides guidance to assist in the development, implementation, and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for medical devices and related services.
Areas Covered in the seminar:
The participant will understand the Supplier Management requirements in QSR and the reasoning behind the current regulations.
The participants will be able to compare and contrast the QSR requirements with the ISO 13485 requirements. In addition, the participant will be able to identify some of the best practices from ISO/TR 14969:2004.
The participant will be able to identify the six general principles from the GHTF guidance document and implement methods based on these principles.
Who will benefit:This seminar is designed for all employees involved in supply management. In particular, it is aimed at cross-functional multi-discipline teams who manage supplies or commodities. This typically includes:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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