When we launched the DeSantis Consulting Associates website a couple of months ago I posted my first blog, welcoming all my friends and colleagues to the website and explaining a little about why I decided to “go digital”. For those of you who did not have a chance to read that piece, sorry you missed it. It is gone, relegated to that mysterious graveyard of lost documents that the author (or the author’s trusty webmaster) neglected to save on a hard drive or in the Cloud.

In any case, I have decided to again welcome everyone and anyone who has the time and inclination to read the thoughts of a “veteran” industry observer and occasional critic. If you read the first blog, I have attempted not to repeat myself in this one. For those of you who missed it, I am sorry to have not included some of the clever quips provided therein.

For those of you who may not know me, I have been around the Pharmaceutical Industry since 1969. I have worked in manufacturing management, technical support, quality operations, validation and engineering. I have molded my interests and experiences to contribute to the broad field of Pharmaceutical Engineering and the more specific focus of Engineering Compliance. What interests me most is the application of engineering principles and expertise to the development and manufacture of high-quality drugs and biologicals. I believe in science and technology and I abhor waste. I have seen the industry change, sometimes radically and sometimes painfully, from a chaotic, exciting period of growth to one of seeming stagnation. I have seen so many hopeful and energetic firms working within a landscape of almost limitless opportunity, only to be swallowed up by the the combined forces of misunderstood and mis-applied regulation and bad management. The result has been a gradual consolidation into a few gargantuan entities, driven by the quarterly earnings report and bogged down by the complexity and inefficiency of their own mass. In summary, the little guys with the ideas and the energy don’t have the finances or the resources to succeed, while the big firms are unwilling to invest in the business at the expense of the immediate bottom line.

So from the preceding paragraph, you can see that this blog is about opinion. I am not a Wall Street analyst, but I see what I see. My hope is that my opinions will at least get people thinking and that one or two or a few of these will make some kind of difference. I will attempt to write about things I consider myself well-versed in, like quality systems or validation, but I might just make an observation on pretty much anything else related to our industry. I will stay mostly on the operations/manufacturing/quality side of the business and away from the R&D/medical issues. It seems to me that we need work on both, but I won’t waste your time or my own on issues I know nothing about. I hope to contribute regularly (my web advisor says weekly would be good). I might write on a theme (e.g., Quality Risk Management) or might just shoot from the hip on a random albeit interesting subject.

Once again, welcome to the blog and the site and feel free to post comments and tell your friends.