New Course: Lean & Agile DOE for QbD
I’d like to begin sharing my lessons learned with the community–a “practical” approach that I have been developing while working in the trenches of the Biotechnology industry. For now, I call it “Lean & Agile DOE for QbD.” As a researcher-for-life, I observed what worked and what did not. After extracting the best practices that actually worked and taking out those that failed, I have been testing and refining the approach with my fellow scientists and engineers to continuously improve it. I’m a tinkerer so this will always be in a Beta version.
Of many, this is the first one I will share. I’m calling it:
Lean & Agile Design of Experiments (DOE) for Quality by Design
1. The goal of the course is to map the “Design Space” in an effective & efficient way.
Most QbD submissions failed due to this — not correctly mapping a “Design Space.”
Design Space is the core element of Quality-by-Design approach. Properly doing this will provide financial benefits to the company–quality improvement, regulatory relief, faster time-to-market, etc.
2. Another important Aha! lesson for me: Knowledge is insufficient to transform behavior and practices. A business process must accompany the transformation to enable the knowledge. In R&D it was how R&D projects were managed. We need to change how R&D projects are run. (More on this soon). This course will provide the right project management fit for the ever-changing R&D.
In the forthcoming weeks, I will begin to share the contents and lessons with the community. Please sign up to receive updates.
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