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    US Individual: $220
    Non US Individual: $280
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Process Validation Requirements & Industry Practice Workshop

This 2 1/2 day course provides attendees with practical tools and techniques for process validation requirements for FDA’s Quality System Regulation and recognized Process Validation Guidance from the Global Harmonization Task Force. The program includes industry best practices and real life process validation examples.

• Determine which processes require validation and develop a Master Validation Plan
• Develop protocol content to ensure a successful validation
• Document the results and the resolution of deviations that occur during validation
• Plan for effective monitors and controls for the validated processes
• Determine the revalidation requirements for product and process changes

Format
This 2 1/2 day program provides intensive coverage of process validation includes a variety of real life examples, case studies, and exercises that cover process validation activities. These exercises provide participants with the opportunity to apply new information to actual validation scenarios. The course includes a general description of statistical methods and tools as they relate to process validation.

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