Statistics for FDA Process Validation Using JMP Software
Business Knowledge Series course
The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled "Process Validation: General Principles and Practices," consists of a three-stage process. The three stages are Process Design, Process Qualification, and Continued Process Verification. Although the guidance was established for the pharmaceutical industry, it also provides a useful framework for other industries. This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents. Analyses in this course use the point-and-click interface of JMP software from SAS.
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Who should attend
Before attending this course, you should attend the course JMP Software: A Case Study Approach to Data Exploration It is also strongly recommended that you attend the course JMP Software: ANOVA and Regression
This course addresses JMP software.
Introduction to Statistics for Process Validation