Increase your market edge with:

• Successful FDA, E.U. and third-party inspection strategies
• Effective CAPA management
• Best practices for reducing design complexity
• Principles of process and software validation
• Essentials of effective risk management systems

Featuring Keynote Presentation by:

• The FDA's Outlook for Quality in Device Manufacturing
  Timothy Ulatowski
  Director, Office of Compliance
  Center for Devices and Radiological Health
  U.S. Food & Drug Administration
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Plus 2 Important Panel Discussions:

1. QSIT Experiences To Date/Traditional Inspections
2. Management Responsibility for QA/RA
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Pre-Conference Workshop:
Developing Your Quality System to Incorporate Global Standards:

• ISO 13485:2003
• ISO 9001:2000
• FDA’s Quality System Regulation
• Europe’s CE Marking Requirements
• Canada’s Medical Devices Regulations
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