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Because of rapid developments in the biotechnology industry-and the wide range of disciplines that contribute to its collective growth-there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a c

Produktbeschreibung
Because of rapid developments in the biotechnology industry-and the wide range of disciplines that contribute to its collective growth-there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a c

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Autorenporträt
Michael J. Roy, Ph.D., RAC, is an adjunct professor in the Master of Science Biotechnology Program in the School of Medicine and Public Health at the University of Wisconsin-Madison. He teaches Biotechnology Operations and Project Management and Leadership. He has successfully developed biopharmaceutical and medical device products for more than 22 years, serving as a consultant in biotechnology since 2001. Much of his work has focused on early development of novel biotechnology products and medical devices with emphasis on product development planning, regulatory affairs, quality systems, and project management.

He received a Ph.D. in Pathology from University of Wisconsin-Madison, an MS in Tropical Medicine and Medical Parasitology from Louisiana State University Medical Center, and a BS in Biology from the University of Wisconsin-Platteville. In addition, he holds Regulatory Affairs Certification (RAC).

Mr. Roy is a retired colonel in the U.S Army. While serving, he was involved in the development of in vitro diagnostics and vaccines and in establishing ISO (International Organization of Standards) quality systems at the U.S. Army Medical Research Institute of Infectious Diseases, Ft. Detrick.