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In addition to the efficacy and safety of pharmaceutical products and devices, a major goal of the manufacturing process is the uniformity of products. Hence pharmaceutical companies use statistical process controls (SPC) to contain the stability, variability, and capability of the manufacturing process. This course introduces you to the basics of calibrating processes and determining standards for evaluation of the reproducibility of the products of your manufacturing process. It includes lessons on control charts, measures of central tendencies, measures of variability, and other statistical tools.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Lesson 1: Statistical Basis of the Control Chart
Lesson 2: Control Charts
Lesson 3: The x-Bar Charts
Lesson 4: The Range (R) Charts
Lesson 5: The p-Charts
Lesson 6: The c-Charts