{"product_id":"risk-management-applications-in-pharmaceutical-and-biopharmaceutical-manufacturing-isbn-9780470552346","title":"Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing","description":"\u003cp\u003e\u003cb\u003eSets forth tested and proven risk management practices in drug manufacturing\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eRisk 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eRisk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eBasic foundation of risk management principles, practices, and applications\u003c\/li\u003e \u003cli\u003eTested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes\u003c\/li\u003e \u003cli\u003eRecent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing\u003c\/li\u003e \u003cli\u003eCase studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing\u003c\/li\u003e \u003cli\u003eBibliography and extensive references leading to the literature and helpful resources in the field\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWith 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.\u003c\/p\u003e \u003cp\u003ePreface vii\u003c\/p\u003e \u003cp\u003eContributors xi\u003c\/p\u003e \u003cp\u003eAbout the Authors xiii\u003c\/p\u003e \u003cp\u003e1 Background and Introduction 1\u003cbr\u003e\u003ci\u003eHarold S. Baseman and A. Hamid Mollah\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 Risk Management Tools 17\u003cbr\u003e\u003ci\u003eMark Walker and Thomas Busmann\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration 49\u003cbr\u003e\u003ci\u003eMike Long\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Statistical Topics and Analysis in Risk Assessment 75\u003cbr\u003e\u003ci\u003eMike Long\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Quality by Design 89\u003cbr\u003e\u003ci\u003eBruce S. Davis\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 Process Development and Clinical Product Manufacturing 101\u003cbr\u003e\u003ci\u003eKaren S. Ginsbury\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment 129\u003cbr\u003e\u003ci\u003eHarold S. Baseman and Michael Bogan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Process Lifecycle Validation 179\u003cbr\u003e\u003ci\u003eA. Hamid Mollah and Scott Bozzone\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Aseptic Processing: One 227\u003cbr\u003e\u003ci\u003eJames P. Agalloco and James E. Akers\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Aseptic Processing: Two 243\u003cbr\u003e\u003ci\u003eEdward C. Tidswell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Pharmaceutical Product Manufacturing 275\u003cbr\u003e\u003ci\u003eMarlene Raschiatore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 Biopharmaceutical Manufacturing 325\u003cbr\u003e\u003ci\u003eRuhi Ahmed and Thomas Genova\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Risk-Based Change Control 367\u003cbr\u003e\u003ci\u003eWilliam Harclerode, Bob Moser, Jorge A. Ferreira, and Christophe Noualhac\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 387\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eA. HAMID MOLLAH, PhD,\u003c\/b\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eDr. MIKE LONG,\u003c\/b\u003e 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eHAROLD S. BASEMAN, MBA,\u003c\/b\u003e 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.\u003c\/p\u003e  \u003cp\u003e\u003cb\u003eSets forth tested and proven risk management practices in drug manufacturing\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eRisk 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.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eRisk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing\u003c\/i\u003e 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:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eBasic foundation of risk management principles, practices, and applications\u003c\/li\u003e \u003cli\u003eTested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes\u003c\/li\u003e \u003cli\u003eRecent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing\u003c\/li\u003e \u003cli\u003eCase studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing\u003c\/li\u003e \u003cli\u003eBibliography and extensive references leading to the literature and helpful resources in the field\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWith 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.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47989967093989,"sku":"NP9780470552346","price":146.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780470552346.jpg?v=1761786061","url":"https:\/\/k12savings.com\/es\/products\/risk-management-applications-in-pharmaceutical-and-biopharmaceutical-manufacturing-isbn-9780470552346","provider":"K12savings","version":"1.0","type":"link"}