FDA 483 inspection

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FDA 483 inspection 0:23:34

FDA 483 inspection

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FDA inspection resources 0:04:53

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Preparing for a 0:02:27

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What Not To 0:03:49

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Комментарии
Автор

Also, in "All process there is variance" like Deming would say....FDA or anyone can find "anything"...no need to stress it....the objective is to "manage it"....

JohnSmith-vqkf
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Great advice...but, few companies have the resources to execute on this advice....just saying...been there done that...at my last company, I was the ONLY ONE trying to do all this myself...it was a disaster....surprised we "got by"...I would put more details here, but it may identify what company I worked at...I was working 20 hours days...I finally, just quit..it was not worth it..

JohnSmith-vqkf
Автор

Great advice overall...but companies really don't care in the end...that is the bottom line...they just want to "Get by"....even had my manager lie to FDA many times....hahaha

JohnSmith-vqkf
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"War Room" is silly....just call it AUDIT ROOM....hahaha

JohnSmith-vqkf
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Unfortunate, we can't be honest with the FDA....there should be an IMMUNITY CLAUSE...and the FDA audit should be used to IMPROVE things....hahahah

JohnSmith-vqkf