A Foundation For Quality (and performance...)

Next week is ISPE’s annual meeting in Texas and once again I am participating in an interesting session titled “Operational Excellence - A Foundation for Quality”. We held a similar session last year and it was a great success with more than 90 people participating. The topic that I am covering this year is about the current capabilities of automation technology andinformation systems that provide a vital ingredient in enabling operational excellence. I will be joined by speakers from Pfizer, Celgene, Amway and of course NNE Pharmaplan.

My co-presenters will share experiences about OperationalExcellence, Quality by Design (QbD), and Process Understanding. All-in-all an interesting combination of topics that may initially seem loosely related but they are in fact deeply related. They stem from the some old notion that manufacturing performance is a holistic concept. I have mentioned in a previous post that we are “re-inventing the CIM wheel” but at the same time we are also looking at it in a new perspective with much more modern and usable technologies.  I strongly believe that before we venture with new ideas we have to look and learn from the past, it is very likely that somebody has had a similar problem and may even have a solution. So CIM, PAT, QbD, DFM it really is all related, related to trying to excel at we do and work more synergistically to accomplish our manufacturing goals.