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hardcover. Zustand: Sehr gut. Seiten; 9780470552346.2 Gewicht in Gramm: 1.
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In den WarenkorbZustand: New. A. HAMID MOLLAH, PhD, is the Head of Quality Engineering and Validation at XOMA. He has also held positions at Genentech and Baxter. He is a RAPS Certified Regulatory Affairs Professional and ASQ Certified Quality Engineer.Dr. MIKE LONG, has two decades of .
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In den WarenkorbHardcover. Zustand: Brand New. 1st edition. 416 pages. 9.45x6.50x1.04 inches. In Stock.
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Buch. Zustand: Neu. Neuware - This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective risk management approaches, and includes case studies to help with understanding.
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In den WarenkorbHardback. Zustand: New. This item is printed on demand. New copy - Usually dispatched within 5-9 working days.
Sprache: Englisch
Verlag: John Wiley & Sons Inc, New York, 2013
ISBN 10: 0470552344 ISBN 13: 9780470552346
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Erstausgabe Print-on-Demand
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In den WarenkorbHardcover. Zustand: new. Hardcover. Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applicationsTested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processesRecent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturingCase studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturingBibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing. This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.