Agent Gxp FDA Part 11 Guidebook

Agent Gxp FDA Part 11 Guidebook

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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 them to new situations, and how to prepare for enforcement of Part 11. This is particularly important for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries, and provides an excellent glimpse of the issues that are likely to face HIPAA implementation of electronic records security measures. This course has been used by thousands of people in the pharmaceutical industry. Readers will enjoy the approachable, compact, conversational style of the title. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version. This is part of the highly acclaimed UniversityOfHealthCare series on FDA regulations.... cost savings from the reduced need for storage space, reduced errors, data integration/trending, product improvement, manufacturing ... automated databases that enable more advanced searches of information, thus obviating the need for manual searches of paper records; ... One comment said that FDAa#39;s position on electronic signatures/electronic records is one of the most pressing issues for theanbsp;...

Title:Agent Gxp FDA Part 11 Guidebook
Author: Daniel Farb, Daniel Farb, M.D., Bruce Gordon
Publisher:UniversityOfHealthCare - 2005-07-01

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