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Statistical Design Space Development for Pharma from Design of Experiment to Granules Master of Solids Certification Seminar October 07 to 08, 2015 www.boschpackaging.com×academy Your successful
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Identify the variables and factors that will be considered in the statistical design space development. These can be both input and output variables that will be analyzed and optimized.
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Choose the appropriate statistical tools and techniques for the analysis and optimization process. This can include methods like design of experiments (DOE), statistical process control (SPC), or response surface methodology (RSM).
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Develop a statistical model that represents the relationship between the variables and factors in your design space. This model will help you understand the impact of different factors on the desired outcomes.
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Conduct the statistical analysis and optimization process using the chosen tools and techniques. This may involve running experiments, collecting data, and analyzing the results.
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Evaluate and interpret the results of the statistical design space development. This will help you understand the strengths and weaknesses of your design space and make informed decisions for further improvements.
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Regulatory bodies and authorities may require statistical design space development as part of compliance and validation processes, especially in sectors where safety and quality are critical.
Overall, statistical design space development is relevant for any individual or organization that aims to optimize processes, enhance quality, and make data-driven decisions.
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Statistical design space development is the process of determining the optimal range of input variables and process parameters that will result in a high-quality product.
Companies involved in the manufacturing of pharmaceuticals or other regulated products are required to file statistical design space development.
Statistical design space development is typically filled out by utilizing statistical tools and conducting experiments to identify the critical process parameters.
The purpose of statistical design space development is to ensure that the manufacturing process is robust and capable of consistently producing high-quality products.
Statistical design space development must include details on the critical process parameters, their ranges, and the justification for selecting these parameters.
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