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Device manufacturers face issues and confusion when setting up and maintaining a supplier management program. Some of this confusion results from the regulations. While they contain requirements, the details are dependent on the device manufacturer’s ability to create an effective and efficient system.

This workshop will help the device manufacturer through a unique format of explanation, discussion, and practical application. The course is built of modules based on the Global Harmonization Task Force (GHTF) guidance document on the control of products and services obtained from suppliers. It describes the necessary controls in a model that includes six phases:

  • Planning
  • Selection potential suppliers
  • Supplier evaluation and acceptance
  • Establishing controls
  • Delivery, measurement, and monitoring
  • Feedback and communication, including Corrective Action and Preventive Action processes

The course follows these phases and explains the regulatory requirements in the Quality System Regulation (QSR), ISO 13485:2003, the Medical Device Directive (MDD), EN ISO 13485:2012, and other requirements.

Contact the event managers listed below for more information about how you can participate at the Managing Suppliers in the Medical Device Industry.

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Conference/Event Dates: 04/07/2016 - 04/08/2016
Conference/Event Hours: 16
Expo/Exhibit Dates: 04/07/2016 - 04/08/2016
Expo/Exhibit Hours: 24
First Move-In Date: 04/06/2016
Classification: B2B
Primary Industry: Medical
Other Industries: Manufacturing, Medical
Estimated Attendance: 20
Previous Attendance: 7
Cost to Attend: $1,200 usd
Audience: Quality Managers
Supply Chain Managers
Quality Engineers
Supplier Quality Engineers
Purchasing Professionals
Regulatory Specialists
Production and Process Engineers
Design and Development Engineers
Verification and Validation Specialists
Notes: Upon course completion, participants will:

Understand FDA QSR and ISO 13485:2003 requirements for supplier management
Understand the FDA's multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Use an analysis matrix and radar chart to compare suppliers

and so on
Venue: Hilton Chicago
Venue Phone: (609) 256-4556
Venue Type: Indoor - Hotel

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

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Managing Suppliers in the Medical Device Industry

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