This title is part of the UniversityOfHealthCare/ UniversityOfBusiness Interactive Training Library, which offers authoritative, clearly written material in an interactive form for better comprehension and documentation of completion. This is a package of two related products: (1) Agent GXP Part 11, used by thousands in the pharmaceutical industry, teaches the regulations of Part 11 on electronic records through a spoof of a hostage story. 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. It is taught mostly through interactive questions and interviews with Agent GXP. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough course 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...

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