Agent Gxp FDA Part 11 Guidebook

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UniversityOfHealthCare, Jul 1, 2005 - Medical - 215 pages
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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.
 

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Copyright

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Page 204 - It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

About the author (2005)

M. DANIEL FARB, M.D., CEO of UniversityOfHealthCare and UniversityOfBusiness, is a leader in the field of interactive management and healthcare e-learning. He received a BA in English Literature from Yale (where he set an academic record and studied with writers like Robert Penn Warren), an M.D. from Boston University, a degree in Executive Management from the Anderson School of Business at UCLA, and is currently working on a degree at UCLA in International Trade. He is a practicing ophthalmologist. He also has received two patents in ophthalmology and is working on others, has worked with the World Health Organization in Geneva and the National Institutes of Health in Washington, D.C. He has written scientific and popular articles, and has worked as a newspaper reporter. He helped Dr. Robbins edit one of the editions of Robbins' "Pathology" textbook for readability. He wrote an article on humor for the Massachusetts Review. He has experience in theater and television, including acting, directing, and stage-managing. He has programmed his own patient records database. He has written and edited hundreds of e-learning courses. Dr. Farb is a member of the American Academy of Ophthalmology, the Union of American Physicians and Dentists, the AOJS, the American Association of Physicians and Surgeons, the American Society for Training and Development (ASTD), the E-Learning Forum, the Southern California Biomedical Council, the PDA (Parenteral Drug Association), and the Medical Marketing Association. He has taken FDA-level training on Part 11.

University of Healthcare/University of Business is an e-learning company founded in 2000 with a core of talented, multi-disciplinary professionals in Los Angeles who optimize learning material from sources around the world as well as their own resources in Los Angeles. No other company offers what they do in the areas of content, price, service, and quality. The broader public can use many of the titles offered, too. They are all written to inform in a clear, accessible manner.

BRUCE GORDON is the Creative Director for UniversityOfHealthCare. After receiving a BA in Economics from UCLA, he began a freelance writing career that included technical writing (such as a manual for Princess Cruise Lines), stand-up comedy routines for nationally known comedians, and screenplay writing. He has done production support work with famous Hollywood personalities on such well-known productions as Aaron Spelling's "Dynasty" and "Love Boat" TV shows. An audio-visual software specialist, he is a versatile artist, with published works in a variety of media, including music, motion graphics, and digital video short film. He has taken FDA-level training on computer validation.

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