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• Sales Rank: #4354708 in Books
• Published on: 2016-09-07
• Original language: English
• Dimensions: 9.00" h x .7" w x 6.00" l,
• Binding: Paperback
• 28 pages

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Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena. A companion CD-ROM contains dozens of FDA guidance documents and international harmonization documents (ICH and GHTF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.

• Sales Rank: #584305 in Books
• Published on: 2012-06-12
• Original language: English
• Dimensions: 9.00" h x 6.00" w x 1.00" l, 1.10 pounds
• Binding: Paperback
• 288 pages

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4 of 5 people found the following review helpful.
Best book for the topic
By Quality Engineer, Six Sigma black belt
If you are a professional working in the medical industry, I strongly recomend you this book.
It start from a very high level process description(QSR, ISO-standards, GHTF, Quality Management System),to an overview of the most used Risk management tools, to finish with very useful examples and case-studies.
I have found very interesting the description of the interaction between Risk and the different areas of the Quality Management system.
Pros:
- easy to read, very detailed
- it shows the trends in the current industry
Cons:
- missing information about the expectations from regulatory bodies other than USA (but this was the intention of the book)
In summary, a must to have book.

0 of 0 people found the following review helpful.
I recommend it.
By Martin Kvokacka
just started reading it and it helped to answer our questions within company. I recommend it.

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• Sales Rank: #1756792 in eBooks
• Published on: 2011-05-20
• Released on: 2011-05-20
• Format: Kindle eBook

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As the global economic crisis continues to cause damage, some policy makers have called for a more Keynesian approach to current economic problems. In this book, the economists Peter Temin and David Vines provide an accessible introduction to Keynesian ideas that connects Keynes's insights to today's global economy and offers readers a way to understand current policy debates. They survey economic thinking before Keynes and explain how difficult it was for Keynes to escape from conventional wisdom. They also set out the Keynesian analysis of a closed economy and expand the analysis to the international economy, using a few simple graphs to present Keynes's formal analyses in an accessible way. Finally, they discuss problems of today's world economy, showcasing the usefulness of a simple Keynesian approach to current economic policy choices. Keynesian ideas, they argue, can lay the basis for a return to economic growth.

• Sales Rank: #975469 in Books
• Published on: 2014-09-12
• Original language: English
• Number of items: 1
• Dimensions: 9.00" h x .38" w x 6.00" l, .0 pounds
• Binding: Hardcover
• 136 pages

Review

Peter Temin and David Vines's Keynes is highly relevant for today's world. Written in an accessible and lively style, it puts the history of Keynes's thinking into the broader perspective of the history of economic thinking and the history of macroeconomic crises from the interwar years until the present day.

(Thomas Piketty, author of Capital in the Twenty-First Century)

This is the Keynesian story told in real time as Keynes tried to persuade policy makers during the decades between 1919 and 1945. It brings Keynesian thinking alive, and explores how similar today's problems are to those experienced between the wars. Lucidly written for students but also a fascinating exploration of a revolution in economic thought.

(Simon Wren-Lewis, Professor of Economics, Merton College, University of Oxford)

John Maynard Keynes was one of the towering intellectual figures of the twentieth century and, as a result of the global financial crisis, one of the most controversial figures of the twenty-first. Peter Temin and David Vines, with characteristic clarity, explain precisely why. In so doing they dispatch much unnecessary and unfortunate confusion about the man, the work, and the legacy.

(Barry Eichengreen, George C. Pardee and Helen N. Pardee Professor of Economics and Political Science, University of California, Berkeley)

About the Author

Peter Temin is Elisha Gray II Professor Emeritus of Economics at MIT and the author of Lessons from the Great Depression (MIT Press) and other books. David Vines is Professor of Economics and Fellow of Balliol College at the University of Oxford, and joint editor of a number of books on global economic governance. Temin and Vines are coauthors of The Leaderless Economy: Why the World Economic System Fell Apart and How to Fix It.

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15 of 16 people found the following review helpful.
Valuable contribution to Keynesian literature
By E. Ray Canterbery
This is an up-to-date review of Keynesian economics in understandable prose. It extends Keynes' closed economy model to the global system. This is a valuable introduction to Keynes.

9 of 9 people found the following review helpful.
Keynes is still applicable to today. This is a ...
By Larry G. Brandt
Keynes is still applicable to today. This is a presentation that makes him understandable without having to read the 3 books that give his theory.

8 of 10 people found the following review helpful.
If you're a lay person who wants to understand the ...
By Ruddyoak
If you're a lay person who wants to understand the current economy and the ways in which tax policy and government are part of the solution, and not--as you've been lead to belive since Reagan--the problem, this is a book to read.

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• Sales Rank: #2178595 in Books
• Brand: Brand: Timeless Books
• Published on: 2007-03-21
• Original language: English
• Number of items: 1
• Dimensions: 5.75" h x 4.25" w x .50" l, .25 pounds
• Binding: Paperback
• 117 pages

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• Used Book in Good Condition

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[X744.Ebook] PDF Ebook Silicon Processing for the VLSI Era, Vol. 1: Process Technology, by Stanley Wolf, Richard N. Tauber

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Silicon Processing for the VLSI Era, Vol. 1: Process Technology, by Stanley Wolf, Richard N. Tauber

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• Sales Rank: #381906 in Books
• Brand: Brand: Lattice Press
• Published on: 1986-01
• Original language: English
• Number of items: 1
• Dimensions: 9.50" h x 7.25" w x 1.00" l,
• Binding: Hardcover
• 660 pages

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• Used Book in Good Condition

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25 of 28 people found the following review helpful.
Silicon Processing for the VLSI Era
By Jerry T. Healey
This book provides an outstanding presentation of Silicon processing technology that is technically current, rich in detail, and most importantly, factually correct. The new edition of this book appears to have been completely rewritten, and covers every important area of Silicon processing in a comprehensive manner. I especially enjoyed that fact that in each chapter of the book the basic principles underlying a technology are explained first, and these explanations are then integrated into descriptions of the relevant technology (i.e. PVD, CVD, CMP etc.).
The two Lithography sections are beautifully done, and contain lucid explanations of concepts that I have not seen anywhere else.
For anyone who is seriously interested in semiconductor manufacturing, this book is a "must have". No other volume even comes close to being this comprehensive.

7 of 8 people found the following review helpful.
Silicon Processing for the VLSI Era
By Jerry T. Healey
This book provides an outstanding presentation of Silicon processing technology that is technically current, rich in detail, and most importantly, factually correct. The new edition of this book appears to have been completely rewritten, and covers every important area of Silicon processing in a comprehensive manner. I especially enjoyed that fact that in each chapter of the book the basic principles underlying a technology are explained first, and these explanations are then integrated into descriptions of the relevant technology (i.e. PVD, CVD, CMP etc.).
The two Lithography sections are beautifully done, and contain lucid explanations of concepts that I have not seen anywhere else.
For anyone who is seriously interested in semiconductor manufacturing, this book is a "must have". No other volume even comes close to being this comprehensive.

9 of 11 people found the following review helpful.
THE best set of technical references in this area
By Dennis E. Schrope
In my 25 years of semiconductor process development I have never come across such a complete and in-depth collection of device and process knowledge in a single place. Years ago we needed to spend many hours with the journals to extract the requisite information to supplement our laboratory efforts. These volumes synthesize the basics with the most modern techniques now employed in advanced technologies. In addition, many subtle processing difficulties are addressed as well which will be much appreciated by the researcher. Through the years I have purchased in excess of 100 text references and none comes as close to these in the total knowledge contained within. These volumes are intended for the researchers and engineers working in this field yet they are so very well written and easy to comprehend that any one with such an interest in this field can understand them. Study these volumes completely.

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[V578.Ebook] Ebook Download Acing Criminal Procedure (Acing (Thomson West)) 1st (first) edition

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• Published on: 2006-08-16
• Binding: Paperback

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