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There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. The revised book includes: a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources.

After reading this book, individuals involved in medical product development, regardless of their background or functional discipline, will understand all facets of the process—from idea creation through to commercialization and marketing..
Price: $41.16 [Notify me when price goes down.]

Americans are deeply divided over the Second Amendment Some passionately assert that the Amendment protects an individual's right to own guns. Others, that it does no more than protect the right of states to maintain militias. Now, in the first and only comprehensive history of this bitter controversy, Saul Cornell proves conclusively that both sides are wrong.
Cornell, a leading constitutional historian, shows that the Founders understood the right to bear arms as neither an individual nor a collective right, but as a civic right--an obligation citizens owed to the state to arm themselves so that they could participate in a well regulated militia. He shows how the modern "collective right" view of the Second Amendment, the one federal courts have accepted for over a hundred years, owes more to the Anti-Federalists than the Founders. Likewise, the modern "individual right" view emerged only in the nineteenth century. The modern debate, Cornell reveals, has its roots in the nineteenth century, during America's first and now largely forgotten gun violence crisis, when the earliest gun control laws were passed and the first cases on the right to bear arms came before the courts. Equally important, he describes how the gun control battle took on a new urgency during Reconstruction, when Republicans and Democrats clashed over the meaning of the right to bear arms and its connection to the Fourteenth Amendment. When the Democrats defeated the Republicans, it elevated the "collective rights" theory to preeminence and set the terms for constitutional debate over this issue for the next century.
A Well Regulated Militia not only restores the lost meaning of the original Second Amendment, but it provides a clear historical road map that charts how we have arrived at our current impasse over guns. For anyone interested in understanding the great American gun debate, this is a must read.
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The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors This book is designed to help Quality management professionals in Biomedical, Pharmaceutical, Tissue, and Medical Device industries design a CAPA Quality subsystem that meets and exceeds CAPA requirements in 21CFR 820.100(J).This book accomplishes the following: · Defines CAPA · Provides cross-functional process flows · Provides requirements for a CAPA system · Provides examples for the document hierarchy needed · Provides definitions for a CAPA system · Provides examples of work instructions, and standard operating procedures for a CAPA system..
Price: $22.69 [Notify me when price goes down.]

This volume focuses on the role of motivational processes – such as goals, attributions, self-efficacy, outcome expectations, self-concept, self-esteem, social comparisons, emotions, values, and self-evaluations– in self-regulated learning. It provides theoretical and empirical evidence demonstrating the role of motivation in self-regulated learning, and discusses detailed applications of the principles of motivation and self-regulation in educational contexts. Each chapter includes a description of the motivational variables, the theoretical rationale for their importance, research evidence to support their role in self-regulation, suggestions for ways to incorporate motivational variables into learning contexts to foster self-regulatory skill development, and achievement outcomes.

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Presents a comprehensive description of major theoretical perspectives guiding research and lays out important new theoretical ground on how students become self-regulated learners. Focuses not only on research & theory, but also on instructional practic.
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This book is part of the Division 15 series "Psychology in the Classroom," which is aimed at elementary, middle, and high school teachers The goal of this series is to encourage teachers to base their daily classroom practices on sound principles derived form the latest educational psychology research. The series thus bridges the gap between theory and practice. Each book is written in an accessible, straightforward style and contains a wide range of user-friendly features, such as real-life case illustrations, sample classroom activities, self-study questions, and suggested readings. Every teacher would like to have a classroom full of "smart learners." This accessible guide for midddle school and high school teachers will show the reader how, through self-regulatory training and development, the classroom can be converted into a learning academy full of motivated, empowered students. Teachers will learn how to help students develop five essential study skills as part of their regular classroom assignments: time planning and management, text comprehension and summarization, classroom note-taking, test anticipation and preparation, and writing. Five-week curricula models are presented for each skill area..
Price: $11.00 [Notify me when price goes down.]

An increasing number of studies have been conducted on the role of expression and regulation of emotion in health. Emotion Regulation addresses the question of these studies from diverse angles while encompassing conceptual, developmental, and clinical issues. Central concepts discussed in this volume that are related to health include: coping styles and aggression, alexithymia, emotional intelligence, emotional expression and depression, emotional expression and anxiety disorders, in addition to the emotional competence in children.

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