It’s not what you say, it’s how you say it. Has a friend ever given you that precious tidbit of information? Ignore it – at least if you work in an FDA regulated industry. The FDA requires pharmaceutical manufacturers to meet exacting standards when it comes to packaging and labeling their products. It’s no surprise [...]

What do you do when your milk reaches its expiration date? If you’re anything like me, you give it the sniff test and drink it if it smells okay… or pour it in your cereal if it doesn’t smell bad, but it doesn’t quite smell good either. How about that fish that’s been in the [...]

Does your organization fix problems, or find them before they happen? FDA regulators place heavy emphasis on an organization’s corrective and preventative action (CAPA) plans when problems arise, which leads to organizations leaning heavily on CAPA to correct product non-conformances. In theory, reliance on CAPA should work great. In practice, however, organizations only tend to [...]

Your facility works well enough, right? The quality system was instituted years ago and meets the FDA’s Good Manufacturing Practices requirements. The agency’s only popped in for an inspection once or twice, an obvious sign of confidence. Sure, they found one or two minor, easily-fixed violations, but no facility is perfect. You’ve never instituted a [...]

In looking back over the last decade, it would seem that we’ve made some progress in America with respect to our nation-wide obsession with food, weight, and appearance. With eating disorders and body image issues brought to light thanks to made-for-TV movies and sympathetic talk show hosts, America seems to have turned some corner with [...]

The Global Strategic Management Institute recently invited me to begin sharing news and thoughts on FDA-regulated industries and quality control topics. Thinking about this first post, I wondered whether to start things off by rambling on about the importance of quality control or just jump right into recent happenings like Ian Read’s restructuring at Pfizer. [...]