Will the FDA agree that your Intended Use Validations are Valid? Are you the Head of Quality Control, Quality Engineering or Quality Systems for a Bio-pharmaceutical company – and your team has built or...
I always strive to learn how I can maximize my time, to do more with less and thereby increase my effectiveness. I recently asked myself, how can I and my Advantu Team – more...
Author: Charlie Gragg Quality Process Expert The Cost of Quality decreases as the Quality of Product increases. Let me repeat. The Cost of Quality decreases as the Quality of Product increases. Definitions of “Cost of...
~ Let’s stop doing the same thing over and over – expecting different results ~ Whenever I review the latest entries on the FDA Recall List, I’m still surprised when I see the Reason...
Why it’s so important to have an FDA approved Process… Here is the Million Dollar Question – how important is it to have an established process & follow it? When we are asked to...
