validation and compliance services for FDA regulated industries
phone: 734 274 4680
The call came on a relaxing Sunday afternoon. I was just reaching for a second beer. The football game had just started when the phone rang. It was the guard at the front gate of my plant. It ran 24/7, but it had been a quiet weekend before that. 
People have asked me if I believe in global warming. I hesitate to answer that question because belief is an absolute term. It’s binary, a zero or a one. Global warming is a real world issue and rarely in the real world do problems fall exclusively into one category or another. Do we need to act on global warming? That’s another story.
The responsibilities of the Food and Drug Administration and the US Department of Agriculture would seem to be clear cut. FDA is responsible for Food, Drugs, and Cosmetics while USDA is responsible for agricultural products, right? But an agricultural product can become a food, drug, or cosmetic. Where in the supply chain does a product make the transition from one jurisdiction to the other? Well, it turns out to be right in the middle of your sandwich. If it's an open-face sandwich, it's regulated by USDA. If it's closed-face, it's FDA.
Before his fight with Henry Cooper, Muhammad Ali trash talked, 'This is no jive, Cooper shall go in five.' Everyone assumed that he was simply trying to unnerve his opponent. That’s true, but he had a more important goal as well. And he was far from the first person in history to set it.
The body lies unrecognized in the hallway. People hurry past on their way to somewhere, holding their breath until they get upwind. Some step gingerly over it. Some tiptoe around it. One or two glance at you, hesitate, then think better of it.
My business partner, Nicole, has one of the quickest minds in our business, quality consulting for drugs and medical devices. But I’m blown away at her response to the revelation that confronted her during a recent audit. 
Has someone asked you to train a group of people? Maybe you’re the expert on a subject that no-one else in the organization knows how to do. 
Do you ever find yourself facing an impossible task? In our consulting work we frequently have to tell our clients that they need to achieve seemingly unattainable quality goals, while at the same time the market is forcing costs to be cut. The key is how you frame the problem statement.
Why do we say GOOD Manufacturing Practices? Why not Perfect Manufacturing Practices? Do we want our drugs and medical devices to be anything less than perfect? Why not at least Great Manufacturing Practices? How about this? Why not Totally Awesome Manufacturing Practices. 
Companies go through two stages when they try to become compliant with FDA regulations. Stage one is to write all the procedures that translate the regulations into specific actions for the employees. That’s hard enough. In stage two the company has to get all its employees to follow those procedures. Validation & Compliance Institute
Ann Arbor, MI
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