This is a package of Agent GXP FDA Part 11 and
Pharmaceutical Computer Validation Introduction. These two related titles will give the learner an excellent introduction to computer issues in the pharmaceutical industry. Agent GXP FDA Part 11 teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough section will teach you the history of Part 11, the regulations of Part 11, the implementation of Part 11, the applications of Part 11, the ideas behind Part 11 in order to apply them to…
