Editorial Reviews
Book Description
This indispensable reference CD enables you to have the most important pharmaceutical and medical device documents from the federal government available in one convenient CD ROM that installs onto your hard drive. The search feature enables you to search all documents at one time. The CD includes the following categories of FDA and OIG documents: clinical trials, protection of human subjects, IRBs (Institutional Review Boards), Part 11 and computer validation, manufacturing, sales and marketing, FDA procedures, and food additives. The following HIPAA documents are included because they are important for all companies in healthcare: HIPAA Act of 1996, the final rules for privacy, security, and code sets, important federal guidances on the interpretation of the rules, and parts 160, 162, and 164 of section 45 of the Code of Federal Regulations. Altogether, the CD has thousands of pages of documents. 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. You will need Internet access to e-mail us your unique key and receive a password key. License is for one user on one computer. An additional computer owned by the same user will generally be approved at the discretion of the publisher.
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.
Pharmaceutical Regulatory Documents: A Reference of Federal Documents Pertaining to Major Pharmaceutical, Medical Device, Sales, Manufacturing, Electronic ... Included, As An Aid to Compliance,Daniel, M.D. Farb,UniversityOfHealthCare,1594911002,Business & Economics,Business/Economics,Education & Training,Human Resources & Personnel Management,Medical / Nursing,Pharmacy,Reference
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