Agent GXP FDA Part 11 Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, ... and GCP (Good Clinical Practices) (Pt. 11) [Plastic Comb]

Daniel Farb (Author), Bruce Gordon (Author)

Book Description

Publication Date: October 2003 | ISBN-10: 1932634665 | ISBN-13: 978-1932634662

Agent GXP FDA Part 11 teaches the FDA regulations on electronic signatures and records of 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.

Editorial Reviews

Review

Five stars for the series. "of great value to just about anyone who works with prescription drugs." -- Foreword Reviews, December 29, 2004

About the Author

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 ASTD, the E-Learning Forum, the Southern California Biomedical Council, the PDA (Parenteral Drug Association), and the Medical Marketing Association. He has had FDA-level training on Part 11.

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 had FDA level training on Computer Validation.

Product Details

• Plastic Comb: 397 pages
• Publisher: UniversityOfHealthCare (October 2003)
• Language: English
• ISBN-10: 1932634665
• ISBN-13: 978-1932634662
• Product Dimensions: 8.9 x 6.2 x 0.6 inches
• Shipping Weight: 7.8 ounces (View shipping rates and policies)