GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FD
Автор:Daniel, M.D. Farb Год: 2003 Издание: [не указанo] Страниц: [не указано] ISBN: 159491026, 159491026X, 159491026X Book DescriptionThis 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. Themanual accompanying the CD provides a summary of the major points of the CD in a handy format and includes copies of regulations. The GMP Training Package includes Agent GXP FDA Part 11, Pharmaceutical Computer Validation Introduction, and PharmaceuticalQuality Control Lab. These three courses will give the learner an excellent introduction to the most important areas of modern pharmaceutical manufacturing. 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...
