Foundations of Quality by Design are discussed, and methods for generation of Target Product Profile and Critical Quality Attributes are presented. This course requires 8 hours of instruction.

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Areas of focus include: JMP basics, analysis of data for basic engineering and scientific applications including statistics, distribution analysis, capability assessment, variation analysis, comparison tests, sample size selection, hypothesis testing, confidence intervals and multiple factor modeling.

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The course covers both basic and advanced concepts for the design and analysis of experiments. The course requires 16 hours of instruction.

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A key component of pharmaceutical and biotechnology product development is to perform process validation and qualification studies. The basic concepts, requirements and statistical methods for process validation are presented.

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A key component of pharmaceutical product development is to determine product stability and shelf life. The basic statistical assumptions, tests and life predictions methods will be presented with examples. Determination of whether to pool data, use a common slope or fit the data individually will be presented. Sample size selection and stability estimation in compliance with FDA guidance is discussed.

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Course covers the basic concepts and methodologies associated with designing closed loop process controls using statistical process control for variables and attributes data. Variation assessment, subgroup formation, sample size selection, SPC control chart selection, out of control action plan generation are presented along with measures of process capability.

Course Details

Areas of focus include regression and linear and nonlinear modeling.

Course Details