12:4412:44, 23 May 2019diffhist+7,433
GxP
I have 40 years of FDA/EPA/global compliance experience. The page I edited is dangerous to Industry. I train FDA bioresearch monitoring investigators and the current content is consistent with their training. GxP could be a harmless acronym, but it is being misused by the uniformed as a compliance claim.Tags: categories removedreference list removalreferences removed
22 May 2019
12:2312:23, 22 May 2019diffhist−2,857
GxP
The previous version referred to regulations as guidance. This is a dangerous misunderstanding. These regulations protect public health and safety. They are not guidelines. Reference added to the act: FFDCATag: references removed