Category: Control Strategy

Inconvenient Truth: RPN in QbD Risk Assessment

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...

QbD for Vaccines: A-Vax Control Strategy [Slides]

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...