Business Knowledge Series course
Presented by Heath Rushing, co-founder and Principal Consultant, Adsurgo LLC
This course focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Analyses in this course use the point-and-click interface of JMP software.
Learn how to
- Implement QbD principles from discovery through product discontinuation.
- Apply statistics to set specifications and validate measurement systems (assays).
- Use risk management tools to identify and prioritize potential critical process parameters.
- Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs).
- Establish your design space.
- Develop a control plan as part of a risk management strategy.
- Ensure that your process is in (statistical) control and capable.
Who should attend
Scientists and engineers who need to integrate Quality-by-Design (QbD) principles into their pharmaceutical development and quality systems
Formats available | Standard Duration (duration can vary, see event schedule for details) | | |
Classroom: |
3.0 days | | |
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Before attending this course, you should attend the JMP® Software: A Case Study Approach to Data Exploration course. It is also strongly recommended that you attend the JMP® Software: Statistical Decisions Using ANOVA and Regression course.
This course addresses JMP software.