Biotechnology Operations

John M. Centanni is a regulatory affairs specialist with the University of Wisconsin School of Medicine. He has over twenty years of experience in the field. He has been an active consultant in this area with the FDA and a number of biopharmaceutical companies. Michael J. Roy is an emeritus professor, who has been an active educator, practitioner and consultant in biotechnology operations over the past twenty-five years. He has published over 100 referred papers in drug develeopment and biopharmaceutical operations.

Introduction to Biotechnology Operations. Project Management.Regulatory Affairs.Regulatory Compliance.Quality Systems.Biomanufacture. Quality Control. Nonclinical Trials. Clinical Trials.