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Politics : View from the Center and Left
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Doo
To: Doo who wrote (466399)1/27/2021 7:47:10 PM
From: cosmicforce1 Recommendation   of 540769
 
My experience is only compliance with regulatory law in the medical and pharmaceutical process domain. Lawyers populate some of my family tree going back generations.The gal I married became one. I ended up designing processes for medical devices - not as illogical as my formal job training and education might suggest. Then I went through a three month boot camp when I was drafted from system engineering into regulatory compliance at a company under a federal consent decree.

My "legal experience" is one of an engineer with a capacity for reading wordy prose, distilling it into into actionable requirements, making decent judgments about "what is enough", and translating engineering-speak back into things auditors and FDA inspectors could understand - an odd skill set but more obvious from the driver's seat than that of an outside observer.

I'd read through regulations (mostly Title 21 CFR 820 and 211 plus Part 11) and make sound engineering specifications from these regulations and guidance documents. I'd have to read through commentary in the body of these regulations to assess how they were intended to be implemented and what other companies thought about them.

Lawyers and lobbyists writing laws for medical devices is what you would expect. Much of it was actually sensible. Some ill informed or poorly conceived. The FDA would write "non-binding" guidance documents that they could over-ride. It is like having a contract where one of the parties says "Here's what we think you should do but we can change our mind even if you comply with what we said."
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