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.Learn how to
Who should attendScientists and engineers who need to incorporate statistical concepts into their pharmaceutical process validation quality system
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