Pharmaceutical Quality Control Lab Library Edition: GMP (Good Manufacturing Practices) Training for Pharmaceutical Manufacturing, Covering FDA ... of Standard) and OOT (Out of Trend) Results - Softcover

Farb, Daniel, M.D.; Luttrell, Anthony; Kirsch, Robert

Softcover

ISBN 10: 1594910375 ISBN 13: 9781594910371

Publisher: Universityofhealthcare, 2004

Synopsis

Pharmaceutical Quality Control Lab teaches you the history of regulations affecting quality control in pharmaceutical labs and their importance, and then goes into the specifics of dealing with out of standard and out of trend results in a pharmaceutical quality control lab. It contains an interactive flow chart, numerous step -by-step instructions, questions, an SOP model, and a case study. It is suitable for GMP training. Estimated time: 2-5 hours. 199 pages on CD. 61 pages in the manual include a handy printout of the FDA regulations part 210 and part 211. 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.

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.

ANTHONY MARK LUTTRELL currently works as an independent consultant to the pharmaceutical and medical device industries. He specializes in Operations Management and Quality Systems for active pharmaceutical ingredients, finished pharmaceuticals, medical devices, and biological products. He has extensive experience in all aspects of manufacturing, validation, Quality Control, and Quality Assurance in a GMP environment. He has over twenty years experience in the pharmaceutical, biopharmaceutical, and medical device industries. Mr. Luttrell has held numerous positions in industry, from the laboratory bench to executive management. He has worked for Warner-Lambert, Baxter Healthcare, Solvay, and others. Mr. Luttrell has a BA in Biology from Spring Arbor College, an MBA from Oakland University, and advanced management training from the University of Minnesota.

ROBERT KIRSCH holds a Ph.D. in physical organic chemistry from New York University and has accumulated 24 years professional experience as a practicing chemist with the past 13 years managing analytical/pharmaceutical development and technology support operations. Dr. Kirsch has a diverse background which includes analytical methods development, method validation, preparation of technical documentation required for CMC submission in NDAs, ANDAS, BLAs, Supplements, and Annual Reports. His technical strengths include work with HPLC, GC, various types of spectroscopy, organic structure elucidation, and he has extensive experience with lab automation techniques such as data systems, LIMS and Robotics. Dr. Kirsch is the Principal for R.B. Kirsch Consulting Services.

Edition details

• Publisher: Universityofhealthcare
• Publication date: 2004
• Language: English
• ISBN 10: 1594910375
• ISBN 13: 9781594910371
• Binding: Paperback
• Number of pages: 61