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Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing de AH Mollah

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing: Wiley Series in Biotechnology and Bioengineering

Autor AH Mollah
en Limba Engleză Hardback – 25 apr 2013
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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Specificații

ISBN-13: 9780470552346
ISBN-10: 0470552344
Pagini: 432
Dimensiuni: 164 x 237 x 28 mm
Greutate: 0.73 kg
Editura: Wiley
Seria Wiley Series in Biotechnology and Bioengineering

Locul publicării:Hoboken, United States

Public țintă

Pharmaceutical and biological products manufacturing as well as the growing, R&D and regulatory affairs professionals, medical device and food professionals who have nearly identical risk management expectations, students and teachers in the fields of pharmaceutical engineering, pharmaceutical science and technology, and regulatory affairs.

Cuprins

Notă biografică

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 experience leading product, process development, and validation efforts on a wide range of pharmaceutical, medical device, and combination products. He is a frequent speaker and writer on topics such as risk management, quality systems, quality by design, and process validation. HAROLD S. BASEMAN, MBA, Principal and Chief Operating Officer, ValSource LLC, has more than thirty years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several manufacturing and consulting firms.

Descriere

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.