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TODAY :
EVENT DATE
Apr 2016
MoTuWeThFrSaSu
    123
45678910
11121314151617
18192021222324
252627282930 
EXPO DATE
Apr 2016
MoTuWeThFrSaSu
    123
45678910
11121314151617
18192021222324
252627282930 

Venue

Hilton Chicago 720 S Michigan Ave Chicago , Illinois 60605
Tel: (312) 922-4400
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Managing Suppliers in the Medical Device Industry

20 0

Overview

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.

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