3 Reasons Why QbD Risk Assessment is Key + 3 Tips
Have you led or supported a QbD project? Then you will agree that Risk Assessment is a critical piece — like the small hinge that a big door (QbD) revolves around. The activity may seem trivial but has major implications. In fact, QbD revolves around risk assessment. If you...
3 Reasons Why QbD projects get Stuck & What to Do about it
I have seen and experienced many QbD projects get stuck. There are 3 main pillars in Quality-by-Design: Risk assessment; Design Space; Process Analytical Technology. FIGURE: 3 Pillars of Quality-by-Design (QbD) Of the three, many companies seem to be focusing and spending much time on the Risk Assessment piece but not...