This week, I’m at the 2014 PDA Universe of Prefilled Syringes and Injection Devices and 2014 PDA Drug Delivery Combination Products Workshop. Only two talks have “QbD” in their titles. The good news is that QbD jargons and practices are beginning to show up in other sessions. Earlier...

Previously, we learned: To use a RPN scale commensurate at the level of information available. If you are in development stage, High-Med-Low is recommended. When discussing Control Strategy, separate the rankings of Severity and Occurrence. At the development stage, the main goal of Risk Assessment in Quality by Design...

You heard the story about the troubled QbD Risk Assessment meeting.  Picture yourself and 4 scientists starting a meeting in a conference room at 4pm. Scenario: Fighting over a rating of 3 versus 4 Project Lead: Let’s continue our Risk Assessment using FMEA. Today we’ll assess the severity of Quality Attributes to...

I’m excited to share a Case Study on QbD Design Space for Analytical Assay — Screening DOE. Dr. HS Kim from Green Cross kindly shared his slides titled: “QbD using Design of Experiments Application for Analytical Assay.” The data of the experiment comes from Experimental Design in Biotechnology (Statistics: A Series...

If you are applying QbD for Vaccines, this presentation will be helpful. Dr. Hyun Sung Kim presented a summary of A-VAX case study at KOBIA 2014. Dr. HS Kim (HS from hereon) is the Quality Director at Green Cross, Korea. I share my notes with you.  As with any...

I just spoke at KOBIA’s 2014 QbD Workshop. Thanks to my dear friend, Prof. Yoon at Univ. of Mass at Amherst, (who also invited me to BPQC 2014). The QbD workshop had a good turnout of 120 representatives from Korean Biopharmaceutical companies. The sessions included 4 sessions, ending with...

Confession Today, I share an embarrassing story… I did not truly appreciate DOE. When I was teaching Six Sigma topics at Stanford University and Keio University, I only scratched the surface level. Main reason was that most project sponsors could not share their proprietary or confidential details (process parameters), hiding real numbers...

Now that we’ve covered: How to conduct QbD Risk Assessment in a smart way,  I’d like to move onto the next step – QbD Design Space in a smart way. Before we get into details, let’s set up our main tool –JMP– for success. Surprisingly, many JMP users aren’t aware...

I reveal 2 secret practices today – 2 practices that will set your QbD initiative up for success. I call them secrets because they are the most uncommon QbD practices – especially in the United States, where I work and reside. As facilitators of QbD risk assessment meetings, not...

Thanks to you, your company just saved $56,400 in variable cost and $15 Million in opportunity cost. This comes from eliminating 9 unnecessary group meetings, 12 hours of individual work and a minimum of 3 weeks of delay time to market launch. In Steps 1 and 2, we assessed...