Biotechnology Operations - Centanni, John M

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Auteur(s) : Centanni, John M - Roy, Michael J

Editeur : Taylor & Francis Ltd (Sales)

Langue : Anglais

Parution : 01/03/2011

Format : Moyen, de 350g à 1kg

Nombre de pages : 415

Expédition : 386

Dimensions : 23.6 x 16.0 x 2.0

ISBN : 1439830274

Résumé :

Introduction to Biotechnology Operations: Planning for Success. Project Management. Regulatory Affairs. Regulatory Compliance. Quality Systems. Biomanufacture. Quality Control. Nonclinical Studies. Clinical Trials. Glossary. Additional Reading. Practical Problems and Questions.

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Biographie:

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.