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Event:

  • Supplier Quality Agreements for Medical Devices

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Nov 08, 2013 10:00 AM
  • End Time:
  • Friday - Nov 08, 2013 11:30 AM
  • Location:
  • Online
  • This training on medical device supplier management will explain the elements of a supplier quality agreement and discuss practical steps for implementation.

    Why Should You Attend:
    Effective supplier management can help prevent problems and reduce their impact should they occur. With the increased emphasis on supplier management, you can expect strong coverage of this area during an FDA Inspection. The FDA's Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement.
    This 90-minute training will help you understand the FDA QSR requirements, good business practices, and the role of a supplier quality agreement. This webinar will help you set up an effective and FDA compliant supplier management system.

    Areas Covered in this Webinar:
    -FDA QSR Requirements for Purchasing
    -The Supplier Quality Agreement
    -Administrative Elements
    -Compliance
    -Manufacturing, Packaging, and Labeling
    -Documentation and Records
    -Storage and Shipment
    -Change Control
    -Non-Conformance, CAPA, and Complaints
    --Auditing
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