2012 - Medical Device Supplier Quality Agreements - Webinar By GlobalCompliancePanel

Overview: 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 webinar explains the elements of a supplier quality agreement and its 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.
You need to understand the QSR requirements, good business practices, and the role of a quality agreement. This webinar will help you set up an effective system.
Areas Covered in the Session:
Valuable documents that provide understanding
Quality System Regulation (QSR), including the definitions
QSR Preamble
ISO 13485:2003
FDA's Quality System Inspection Technique (QSIT) manual
Warning Letters
Subject Areas covered
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
For each subject area, the webinar includes information from the valuable documents listed above
Who will benefit:
Quality Managers
Regulatory Affairs Managers
Risk Managers
Supply Chain Managers
Purchasing Professionals
Supplier Management Team
Customer Complaint Specialists
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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