Level: Beginner
One of the areas emphasized when developing pharmaceuticals using QbD (Quality by Design) is “Product & Process Understanding.” In particular, “Understanding the Process” means securing knowledge of the relationship between the Critical Quality Attribute (CQA) and the Process Parameter (PP) in the form of Y=f(X's), and this must be secured scientifically and logically through experimental data.
This presentation will cover how to effectively and efficiently analyze data and draw conclusions using JMP to gain knowledge about the process. The subtopics are as follows:
(1) Use of statistical hypothesis testing to confirm key process variables (CPP)
(2) DOE application for process characterization
(3) Utilization of DSD (Definitive Screening Design) for rapid process development
