The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program. Includes case studies from the various industry leaders that demonstrate application of these concepts Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

Business Intelligence (BI) is a solution to modern business problems. This book discusses the relationship between BI and Human Resource Management (HRM). In addition, it discusses how BI can be used as a strategic decision-making tool for the sustainable growth of an organization or business. BI helps organizations generate interactive reports with clear and reliable data for making numerous business decisions. This book covers topics spanning the important areas of BI in the context of HRM. It gives an overview of the aspects, tools, and techniques of BI and how it can assist HRM in creating a successful future for organizations. Some of the tools and techniques discussed in the book are analysis, data preparation, BI-testing, implementation, and optimization on GR and management disciplines. It will include a chapter on text mining as well as a section of case studies for practical use. This book will be useful for business professionals, including but not limited to, HR professionals, and budding business students.

Business Intelligence (BI) is a solution to modern business problems. This book discusses the relationship between BI and Human Resource Management (HRM). In addition, it discusses how BI can be used as a strategic decision-making tool for the sustainable growth of an organization or business. BI helps organizations generate interactive reports with clear and reliable data for making numerous business decisions. This book covers topics spanning the important areas of BI in the context of HRM. It gives an overview of the aspects, tools, and techniques of BI and how it can assist HRM in creating a successful future for organizations. Some of the tools and techniques discussed in the book are analysis, data preparation, BI-testing, implementation, and optimization on GR and management disciplines. It will include a chapter on text mining as well as a section of case studies for practical use. This book will be useful for business professionals, including but not limited to, HR professionals, and budding business students.

This volume presents a pragmatic approach to understanding and capitalizing on contemporary m-commerce trend. It comprehensively encapsulates the evolution, emergent trends, hindrances and challenges, and customer perceptions about various facets of how physical and online retail channels are merging, blurring, and influencing each other in new ways. The rapid rise of m-commerce (or mobile commerce) has led to the emergence of new paradigms in the marketplace. The difference between physical and digital retail is diminishing, and a new "phygital retail" phenomenon is on the rise. Marketers need to understand this emerging paradigm and consider the new opportunities and challenges involved. This volume, M-Commerce: Experiencing the Phygital Retail, provides a comprehensive discussion of the contemporary m-commerce concepts along with the emerging paradigms in a pragmatic way. It presents empirical analyses and reviews on the myriad aspects of m-commerce, including both contemporary academic and business research.

This volume presents a pragmatic approach to understanding and capitalizing on contemporary m-commerce trend. It comprehensively encapsulates the evolution, emergent trends, hindrances and challenges, and customer perceptions about various facets of how physical and online retail channels are merging, blurring, and influencing each other in new ways. The rapid rise of m-commerce (or mobile commerce) has led to the emergence of new paradigms in the marketplace. The difference between physical and digital retail is diminishing, and a new "phygital retail" phenomenon is on the rise. Marketers need to understand this emerging paradigm and consider the new opportunities and challenges involved. This volume, M-Commerce: Experiencing the Phygital Retail, provides a comprehensive discussion of the contemporary m-commerce concepts along with the emerging paradigms in a pragmatic way. It presents empirical analyses and reviews on the myriad aspects of m-commerce, including both contemporary academic and business research.

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.