Biotechnology Operations : Principles and Practices

Introduction to Biotechnology Operations: Planning for SuccessBiotechnology OperationsMarketing, Financial and Business Considerations for DevelopmentProduct Development PlanningSummary of Planning for SuccessProject ManagementProject Management in BiotechnologyBackground of Project ManagementProject Management in BiotechnologyProject Management in Biotechnology OperationsProject Management with Contracts and CollaborationsTools for Effective Project ManagementSummary of Project Management in Biotechnology DevelopmentRegulatory AffairsThe U.S. Food and Drug Administration: Law and Regulations. Read more... Abstract: Introduction to Biotechnology Operations: Planning for SuccessBiotechnology OperationsMarketing, Financial and Business Considerations for DevelopmentProduct Development PlanningSummary of Planning for SuccessProject ManagementProject Management in BiotechnologyBackground of Project ManagementProject Management in BiotechnologyProject Management in Biotechnology OperationsProject Management with Contracts and CollaborationsTools for Effective Project ManagementSummary of Project Management in Biotechnology DevelopmentRegulatory AffairsThe U.S. Food and Drug Administration: Law and Regulations 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 Comprehensive, Practical Guide To Fundamentals. Filling The Void, Biotechnology Operations: Principles And Practices Reflects This Integrative Philosophy, Serving As A Practical Guide For Students, Professionals, Or Anyone Else With Interests In The Biotech Industry. Although Many Books Emphasize Specific Technical Aspects Of Biotech, This Is Perhaps The First To Integrate Essential Concepts Of Product Development And Scientific And Management Skills With The Seven Functional Areas Of Biotechnology: Biomanufacturing Clinical Trials Nonclinical Studies Project Management Quality Assurance Quality Control Regulatory Affairs A Practical Roadmap To Optimizing Biotechnology Operations, This Reference Illustrates How To Use Specific Product Planning, Design, And Project Management Processes To Seamlessly Merge Plans And Efforts In The Key Functional Areas. Applying Lessons Learned Throughout The Nascent History Of Biotech, Author Michael Roy Highlights Developmental Principles That Could Bring Future Products To Market More Safely And Efficiently. Drawing From His Experiences Working In Industry And Teaching A Graduate Course At The University Of Wisconsin, This Hotly Anticipated Book Clarifies Basic Methodologies And Practices To Help Reduce Risks And Resolve Problems As Future Technological Discoveries Are Developed Into Tangible Products. "This book resulted from experiences gained working in biotechnology and while teaching a graduate course entitled Biotechnology Operations and offered to graduate students in the Master of Science (M.S.) in Biotechnology Program at the University of Wisconsin-Madison (http://www.ms-biotech.wisc.edu/ ). In this course we examine the undertaking of developing biotechnology products, focusing on the scientific and management skills of biomanufacturing, clinical trials, non-clinical studies, project management, quality assurance, quality control, and regulatory affairs. The course emphasizes both operational planning for success and integration of plans and efforts in these seven functional areas. The instructors realized from their experience in the biotechnology industry the great need to carefully plan and fully integrate biotechnology development projects. The course is taught in that manner and this book reflects that philosophy with the outcome is a practical guide for students and for those employed or interested in biotechnology"--Provided by publisher. Front Cover; Contents; Preface; Acknowledgments; The Author; Chapter 1: Introduction to Biotechnology Operations: Planning for Success; Chapter 2: Project Management; Chapter 3: Regulatory Affairs; Chapter 4: Regulatory Compliance; Chapter 5: Quality Systems; Chapter 6: Biomanufacture; Chapter 7: Quality Control; Chapter 8: Nonclinical Studies; Chapter 9: Clinical Trials; Glossary; Additional Reading; Practical Problems and Questions; Back Cover Content: Front Cover Contents Preface Acknowledgments The Author Chapter 1: Introduction to Biotechnology Operations: Planning for Success Chapter 2: Project Management Chapter 3: Regulatory Affairs Chapter 4: Regulatory Compliance Chapter 5: Quality Systems Chapter 6: Biomanufacture Chapter 7: Quality Control Chapter 8: Nonclinical Studies Chapter 9: Clinical Trials Glossary Additional Reading Practical Problems and Questions Back Cover