Biotechnology operations : principles and practices - Roy, Michael Joseph; Centanni, John M. (Boca Raton : CRC Press/Taylor & Francis, 2017)
1. Introduction to biotechnology operations : planning for success -- 2. Project management -- 3. Regulatory affairs -- 4. Regulatory compliance -- 5. Quality systems -- 6. Biomanufacture -- 7. Quality control -- 8. Nonclinical studies -- 9. Clinical trials.
Michael J. Roy's name appears first in the previous edition.
Keywords: Biotechnology; Biotechnological process control; Project management; Biotechnology industries