Tiffany Baker, MBA

https://lnkd.in/gjt4GJGf Take the F out of FDA, put the F back into FDA, but what happens if you make the F great again? The FDA stands at the great if not the greatest crossroads of that F future. Many uncertainties for sure, but one certainty is it’s lousy current performance. The agency’s solution under the current administration, -reorganization a favorite of bureaucratic bliss. If certain national political winds hit the battered sails of the agency, it might just knock down the mast period. Now I am not suggesting the agency’s food program will be or is a sail boat without a mast, I am saying it period. These are all opinions from a former FDA employee that did everything from collected melons in the field domestically and internationally to performed Low Acid Can food inspections of the big boys to import operations. So one can say I had my peek under the carpet as they say. Yes the real grass carpet. During the many years doing and supervising this program’s work, one common denominator was observed, barely making it, barely effective on every aspect of it. Now the BowTie announced they will cut the States contract work, the only part of the food inspection program that is actually inspecting, yep what a “F” mess. No doubt that F is on stage.

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On-shoring has been discussed for the last 4-5 years as a growing concern in biotech. The Biosecure Act is counting down the clock now for a big change in how we do business. https://lnkd.in/e8DJHVs4

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https://lnkd.in/gre8mUg8 If one is to look at a common denominator among these five FDA historical cases. We would see time, the time that transpired before the FDA system reacted to the risk. In the FDA business time is risk exposure and by default many times, loss of life. Fast forward to today and cases like the CPAP Phillips device and we see not much has changed in the agency’s timed reaction protecting the consumer to large scale risk. One can play the devils advocate and claim that many other cases were prevented to develop to this national impact. True, but if we are to apply the quality concepts the agency applies on its clients, validation, CAPA, and the rest of GMPs to lessons learned to its own operations what happens? What did the agency learned from all these historical cases that it applied to the Phillips case for example? This week we had one of the largest bottled water recalls in the history of bottled water. If you look at the causes of the recall it is time again. The conditions are time related negligence of company quality control and time related failure of the agency to inspect. Negligence, time after time in reacting to risk, much like most national cases. What are the primary factors that cause this reaction time issues? Maybe we need time to think about it?

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Another great blog by Paul Mason! Find out some key items to consider when evaluating your Quality Oversight program in terms of its ability to detect and address issues before they become a little more painful? #fda #quality #metrics #qualityoversight

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