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Role of Statistics in Quality by Design (QbD) Implementation in Product Development

 Role of Statistics in Quality by Design (QbD) Implementation in Product Development

 

Inna Ben-Anat, Teva Pharmaceuticals USA

Statistical methods and tools are essential to maintain a process that is in control and capable of producing appropriate high quality product. Design of Experiments provides an effective and efficient way to simultaneously test for factor effects and interactions and to describe causative relationships between process parameters or input materials with the quality attributes. JMP Software provides an excellent analytical and visual platform for application of statistical tools needed for Quality by Design implementation that will assure robust Products and Processes.

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