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. When you successfully complete the exam, you will receive a certificate of completion to document your training for the FDA or for employers. Estimated time: 2-3 hours. 153 pages on CD. 86 pages in the manual include a handy printout of several relevant FDA documents. For convenience, the CD contains the text of some of the regulations. The manual accompanying the CD provides a summary of the major points of the CD in a handy format. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. The CD is licensed to play once on any Windows computer; the borrower may purchase the program after that. One library reference activation is included in the price.
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.
