PROCESS VALIDATION 2011

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Managing Process Validation Activities to Efficiently Meet Compliance Expectations

• Implementing a Science and Risk-Based Approach to Commissioning and Qualification in Line with the FDAís Recent Process Validation Guidance
• Risk-Based Validation and Re-qualification of Process & Equipment
• Stability Considerations in Process Validation
• A Roadmap for Implementing the New Process Validation Guidance
• Best Practices for Defining and Executing a Cleaning Validation Program
• Defining the Design Space for Cleaning Validation, Cleaning Process Qualification, and the Continued Verification of a Validated Cleaning Process
• Implementing A System for Continued Process Verification

In Depth Coverage: Understanding FDA’s New Process Validation Guidance: Assess Challenges Associated With the Interpretation and Implementation of the Guidance