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Jon Speer
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food...
    I love standards, and whether you know it, you love standards, too. For example, let’s say a bulb in your lamp goes bad. You drive down to the local hardware store, buy a bulb, come back home, change out the bulb, plug the lamp back in, and... it lights up. You just benefited from at least seven U....
    Managers the world over want to know if things are “in control.” This usually is taken to mean that the process is producing 100-percent conforming product, and to this end an emphasis is placed upon having a good capability or performance index. But a good index by itself does not tell the whole...
    The Pareto principle calls for focus on the vital few rather than the trivial many. While none of ISO 9001’s clauses are trivial—a nonconformance for any of them requires corrective action—ISO 9001 users can avoid most nonconformances by focusing on the clauses that are the most frequent trouble...
    As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests. The goal of any honest pharmaceutical company is to make...

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