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..
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"....
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
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..
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"....
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
Great Advice
Thanks
great, true, useful
Thank you!
"War Room" is silly....just call it AUDIT ROOM....hahaha
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