Welcome to Validation Week 2008

FDA Presentation




FDA's Risk-Based Inspection Model: A Year in Review at the Field Office Level

 

Karyn M. Campbell, Acting Director, Investigations Branch, U.S. Food and Drug Administration

Create Your  Own Event with 39 Interactive Sessions and Workshops:

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• Build Roadmaps for Effective Process, Cleaning and Compuer Validation

• Audit and Train Suppliers on Validation Principles

• Benchmark from Validation Implementation Case Studies on Six Sigma, Utilities, Global Networking, Personnel Training, FMEA, and Many More!

• Ensure Your Facilities and Equipment are Qualified

• Hear New Regulatory Updates on FDA's Update to the 1987 Guidance to Industry on Process Validation, ASTM E2500, ICH, and Other Global Agencies

• Learn How to Write Exceptional Validation Protocols

• Establish Effective Acceptance Criteria for Process Validation

• Handle Deviations and Risk During Validation