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brookefortson

Joined:

Aug 2, 2011

Quality by Design (QbD) using JMP

I recently had the opportunity to sit down with course developer and JMP instructor Heath Rushing to talk about his new course “Quality by Design (QbD) Using JMP Software.” This course focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design principles using design of experiments (DOE). I was interested in hearing about the strategies behind the course development and who would benefit most from the course.

Why did you create this course? Who would benefit from taking it?

My background is in the pharma/biopharma/medical device industry, so naturally, I was teaching JMP courses to these industries. As I was teaching, the same questions keep coming up from scientists and engineers who were developing processes: How does this relate to QbD? How do I determine my key process parameters? How do I establish a design space? How does this relate to risk management? What about process control and capability? What is "power," and why do the regulatory agencies care about it? They were basically asking, "How can we complete our pharmaceutical/process development studies in the manner suggested by the guidance documents and present it in a coherent, organized fashion?" I created this course to help answer those very questions using real-world data sets so the participants could see how the concepts related to their specific functions.

What skills can a student expect to acquire from this course? Would they be able to begin using these newly acquired skills when they return to work?

The key concept of this course is just that, the students work on the steps to the development process using their particular problems. That includes developing their objectives, establishing Critical Quality Attributes (CQAs), determining potential process parameters, designing both a screening and response surface design, developing a presentation, and tying this information into a process control plan. These are tools students can use the next day!

What are the benefits of taking this course?

Engineers and scientists on process/product development teams will understand the suggested methods outlined in regulatory guidance documents, be able to effectively and efficiently implement them to their particular projects, and know how to present results in a coherent and organized manner.

I understand that JMP Training just released the course in Live Web format. How is the Live Web format different from a classroom-taught course?

To be honest with you, I was a little hesitant to develop the course in Live Web. Because the course is so hands-on, most on-site courses break up into product teams to complete the exercises; it is like a working product team meeting! It's similar in the public courses, although many times each person is working on the tools they are going to take back to their product teams. I wasn't sure how this would work out in Live Web. But I found there is a distinct benefit to taking the course in Live Web; students discuss what they learned in between course days with their product teams. I would begin each day answering very specific questions on the tools they were implementing while they were taking the class. It was quite an interesting dynamic.

If you would like to take this course, you can register online. The course is offered in a three-day classroom format or a six-session, half-day Live Web format.

1 Comment
Community Member

Louis F Valente wrote:

Brooke,

I sat in on this course taught by Heath and found it exceedingly useful and helpful to me.