Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

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9780470552346: Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
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Sets forth tested and proven risk management practices indrug manufacturing

Risk management is essential for safe and efficientpharmaceutical and biopharmaceutical manufacturing, control, anddistribution. With this book as their guide, readers involved inall facets of drug manufacturing have a single, expertly written,and organized resource to guide them through all facets of riskmanagement and analysis. It sets forth a solid foundation in riskmanagement concepts and then explains how these concepts areapplied to drug manufacturing.

Risk Management Applications in Pharmaceutical andBiopharmaceutical Manufacturing features contributions fromleading international experts in risk management and drugmanufacturing. These contributions reflect the latest research,practices, and industry standards as well as the authors' firsthandexperience. Readers can turn to the book for:

  • Basic foundation of risk management principles, practices, andapplications
  • Tested and proven tools and methods for managing risk inpharmaceutical and biopharmaceutical product manufacturingprocesses
  • Recent FDA guidelines, EU regulations, and internationalstandards governing the application of risk management to drugmanufacturing
  • Case studies and detailed examples demonstrating the use andresults of applying risk management principles to drug productmanufacturing
  • Bibliography and extensive references leading to the literatureand helpful resources in the field

With its unique focus on the application of risk management tobiopharmaceutical and pharmaceutical manufacturing, this book is anessential resource for pharmaceutical and process engineers as wellas safety and compliance professionals involved in drugmanufacturing.

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About the Author:

A. HAMID MOLLAH, PhD, is the Head of Quality Engineeringand Validation at XOMA. He has also held positions at Genentech andBaxter. He is a RAPS Certified Regulatory Affairs Professional andASQ Certified Quality Engineer.

Dr. MIKE LONG, has two decades of experience leadingproduct, process development, and validation efforts on a widerange of pharmaceutical, medical device, and combination products.He is a frequent speaker and writer on topics such as riskmanagement, quality systems, quality by design, and processvalidation.

HAROLD S. BASEMAN, MBA, Principal and Chief OperatingOfficer, ValSource LLC, has more than thirty years of experience inpharmaceutical operations, validation, and regulatory compliance.He has held positions in executive management and technicaloperations at several manufacturing and consulting firms.

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Book Description John Wiley and Sons Ltd, United States, 2013. Hardback. Condition: New. New. Language: English. Brand new Book. 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. Seller Inventory # AAH9780470552346

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Book Description John Wiley and Sons Ltd, United States, 2013. Hardback. Condition: New. New. Language: English. Brand new Book. 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. Seller Inventory # AAH9780470552346

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