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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.
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