Statistics for FDA Process Validation Using JMP® Software
There is a new version of this course. Please see Statistics for FDA Process Validation Using JMP® Software.
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.Lernen Sie, wie Sie / Learn how to
Zielgruppe / 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: Statistical Decisions Using ANOVA and Regression.
In diesem Kurs wird mit folgenden Software Modulen gearbeitet / This course addresses JMP Software
Introduction to Statistics for Process Validation