Pharmaceutical Computer Validation Introduction Guidebook - Softcover

Daniel Farb; Bruce Gordon

Softcover

ISBN 10: 1594912629 ISBN 13: 9781594912627

Publisher: UniversityOfHealthCare, 2005

Synopsis

Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.

About this title

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 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. 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. Both authors took FDA level training as part of the preparation for this book.

Edition details

• Publisher: UniversityOfHealthCare
• Publication date: 2005
• Language: English
• ISBN 10: 1594912629
• ISBN 13: 9781594912627
• Binding: Paperback
• Number of pages: 111