Now I Know My ABCs, PATs, and QBDs

July 14, 2008

I like to think that my kindergarten teachers weren’t very efficient in my early education or at least didn’t offer many explanations about their approaches or tactics. One year later, I was still coloring everywhere except within the lines, questioning the effectiveness of “nap time” and “quiet hour,” and why the alphabet song presented ‘LMNOP’ as one slurred letter. I like to think this was the behavior of a gifted child. Or so my parents tell me.

Remaining curious and questioning ways to improve should be staples for living. Everyone needs to keep up with constant change, to learn, question and debate new ways of doing things. Any career, particularly in the pharmaceutical industry, requires constant education and training.

We’re covering two important concepts right now: Process Analytical Technology and Quality by Design. Do you really understand what Quality by Design means, and how process analytics fits into your operations? Are you looking for answers?

Pharmaceutical Manufacturing and are introducing a modular, online course that will cover conceptual issues, but focus on implementation and integration, discussing specific technologies and how they can be applied.

Each minute module (now shortened from 40 to 20 minutes) will discuss industry issues and provide detailed examples and illustrations. The first few modules will focus on:

  • QbD - Analyzing in the GMP Sense vs. Predicting in the PAT Sense
  • What’s Critical to Quality: Determining What to Monitor, Survey or Predict
  • Understanding the Design Space, Design of Experiments and What They Mean: Three Pharma Examples

In another 35-minute multimedia program, “PAT Talk,” hosts Jack Carroll and Emil Ciurczak entertain questions and interview thought leaders within the industry. This program is designed for the industry professional who may be confused about where QbD and analytics connect, where they fit in and what they can do for drug development and manufacturing operations. You can tune in and ask the serious questions you need to have answered by experts in spectroscopy and analytics, in an entertaining “Car Talk” format.

Stay tuned on for more multimedia courses and videos that delve into interesting topics to offer answers and facilitate open forum discussion and debate. Take a half hour or so to watch and let us know what you think or what questions/advice you have. Unlike nap time in kindergarten, we promise it won’t be a waste of your time.

About the Author

Michele Vaccarello | Managing Editor