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Sabtu, 29 April 2017

Download Quality Risk Management in the FDA-Regulated IndustryBy José Rodríguez-Pérez

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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.

  • Amazon Sales Rank: #797682 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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Jumat, 28 April 2017

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Reach your fitness and health goals in HALF the time with HIGH INTENSITY INTERVAL TRAINING!2nd Edition updated with exercise illustrations!8 Week Illustrated Tabata Program for Beginners to Advanced.Are you bored of your current training plan and feel that you’re getting limited results? Or are you just beginning your fitness and health journey? Either way it is time to give HIIT a real go because it is a training system that is scientifically proven to work in terms of blasting off the fat, increasing your muscle mass, as well as reducing certain metabolic diseases.HIIT will definitely work whether you are a beginner, a gym junkie or an elite athlete. HIIT is a powerful training method that gives you far quicker physique and health benefits regardless of your baseline fitness levels. Everyone will start to see quick and amazing results due to the effectiveness of this easy to follow training method.HIIT is not complicated and you don’t have to be a rocket scientist to add it in your current training program. Alternatively you can just start afresh and begin your HIIT journey right here! This book has been written for the HIIT Program By A Master Of Science In Exercise In Nutrition Science And Bachelor of Sports Science(Hons.) and includes:

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    • Sales Rank: #950211 in eBooks
    • Published on: 2015-03-28
    • Released on: 2015-03-28
    • Format: Kindle eBook

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    Rabu, 19 April 2017

    Ebook Free THINK Critically (3rd Edition)By Peter Facione, Carol Ann Gittens

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    For courses in Critical Thinking

    Think currency. Think relevancy. Think Critically.
    Think Critically, 2016 presents critical thinking as the optimal approach for solving real-world problems and making important decisions, boosting the relevance of course material to students’ lives. Authors Peter Facione and Carol Ann Gittens employ a simple, practical approach to deliver the core concepts of critical thinking in a way that students can easily understand. Incorporating contemporary material from a wide range of real-life situations, Think Critically’s engaging examples and exercises hammer home positive critical thinking habits of mind that students can use — in the classroom and beyond.

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    • Sales Rank: #104617 in Books
    • Published on: 2015-02-05
    • Original language: English
    • Number of items: 1
    • Dimensions: 10.70" h x .70" w x 8.40" l, .0 pounds
    • Binding: Paperback
    • 432 pages

    About the Author
    Peter A. Facione, PhD, has dedicated himself to helping people build their critical thinking to become better problem solvers and decisions makers. He does this work not only to help individuals and groups achieve their own goals, but also for the sake of our freedom and democracy. Facione draws on experience as a teacher, consultant, business entrepreneur, university dean, grandfather, husband, musician, and sports enthusiast. Now he is taking his message about the importance of critical thinking directly to students through Think Critically.

    “I’ve paid very close attention to the way people make decisions since I was 13 years old,” says Facione. “Some people were good at solving problems and making decisions; others were not. I have always felt driven to figure out how to tell which were which.” He says that this led him as an undergraduate and later as a professor to study psychology, philosophy, logic, statistics, and information systems as he searched for how our beliefs, values, thinking skills, and habits of mind connect with the decisions we make, particularly in contexts of risk and uncertainty.

    A native Midwesterner, Facione earned his PhD in Philosophy from Michigan State University and his BA in Philosophy from Sacred Heart College in Detroit. He says, “Critical thinking has helped me be a better parent, citizen, leader, consultant, teacher, writer, coach, husband, and friend. It even helps a little when playing point guard!” In academia, Facione served as provost of Loyola University–Chicago, dean of the College of Arts and Sciences at Santa Clara University, and dean of the School of Human Development and Community Service at California State University–Fullerton. “As a dean and provost, I could easily see that critical thinking was alive and well in every professional field and academic discipline.”

    Facione spearheaded the international study to define critical thinking, sponsored by the American Philosophical Association. His research formed the basis for numerous government policy studies about critical thinking in the workplace, including research sponsored by the U.S. Department of Education. Published by Insight Assessment, his tools for assessing reasoning are used around the world in educational, business, legal, military, and health sciences. Today, Peter operates his own business, Measured Reasons. He is senior level consultant, speaker, writer, and workshop presenter. His work focuses on strategic planning and leadership decision making, in addition to teaching and assessing critical thinking. With his wife, who is also his closest research colleague and co-author of many books and assessment tools, he now lives in sunny Los Angeles, which he says, “suits [him] just fine.” You can reach him at pfacione@measuredreasons.com.

    Carol Ann Gittens, PhD, is an Associate Dean in the College of Arts & Sciences at Santa Clara University (SCU). She is an associate professor with tenure in the Liberal Studies Program and directs SCU’s undergraduate pre-teaching advising program and the interdisciplinary minor in urban education designed for students interested in pursuing careers in PreK-12 education.

    Gittens was the founding Director of Santa Clara University’s Office of Assessment from 2007 to 2012. As assessment director, she performed key activities related to institutional re-accreditation, educated academic and cocurricular programs in the assessment of student learning, and designed and oversaw an innovative multiyear, rubric-based assessment plan for a new core curriculum. She is an educational assessment mentor and accreditation evaluator for the Western Association of Schools and Colleges (WASC) as well as Board of Institutional Reviewers member of the California Commission on Teacher Credentialing (CTC), and a senior research associate with Insight Assessment, LLC.

    The central focus of Gittens’ research is on the interface of critical thinking, motivation, mathematical reasoning, and academic achievement of adolescents and young adults from diverse cultural and ethnic backgrounds. Dr. Gittens is an author or co-author of numerous articles and assessment tools focusing on critical thinking skills, numeracy, and dispositions in children and adults. As of this writing, her forthcoming paper is “Assessing Numeracy in the Upper Elementary and Middle School Years.”

    Gittens’ consulting activities include working with college faculty, staff and administrators, PreK-12 educators, as well as business executives, managers, and employees. Dr. Gittens’ areas of expertise include assessment of institutional effectiveness and student learning outcomes, institutional and professional accreditation planning, translating strategic vision into measureable objectives, designing sustainable assessment systems at all levels of the institution, critical thinking pedagogy and assessment, integrating critical thinking and information literacy across the curriculum and in cocurricular programs, as well as statistics and assessment design for individuals and institutions. Gittens earned her PhD in Social and Personality Psychology from the University of California at Riverside.

    She received her BA in Psychology and Women’s Studies from the University of California at Davis. Prior to her appointment at Santa Clara University she taught at California State University, San Bernardino and at Mills College in Oakland, California. Gittens and her husband live in California’s Silicon Valley with their teenaged daughter and son, and their 4-year-old daughter. She is an active parent volunteer in her children’s school, and is involved with K-12 schools in the local community, offering teacher training workshops on nurturing and assessing students’ critical thinking.

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    Senin, 17 April 2017

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    • Sales Rank: #485212 in eBooks
    • Published on: 2015-02-27
    • Released on: 2015-02-27
    • Format: Kindle eBook

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    Sabtu, 15 April 2017

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    The Will to Empower: Democratic Citizens and Other SubjectsBy Barbara Cruikshank

    How do liberal democracies produce citizens who are capable of governing themselves? In considering this question, Barbara Cruikshank rethinks central topics in political theory, including the relationship between welfare and citizenship, democracy and despotism, and subjectivity and subjection. Drawing on theories of power and the creation of subjects, Cruikshank argues that individuals in a democracy are made into self-governing citizens through the small-scale and everyday practices of voluntary associations, reform movements, and social service programs. She argues that our empowerment is a measure of our subjection rather than of our autonomy from power. Through a close examination of several contemporary American "technologies of citizenship"―from welfare rights struggles to philanthropic self-help schemes to the organized promotion of self-esteem awareness―she demonstrates how social mobilization reshapes the political in ways largely unrecognized in democratic theory. Although the impact of a given reform movement may be minor, the techniques it develops for creating citizens far extend the reach of govermental authority. Combining a detailed knowledge of social policy and practice with insights from poststructural and feminist theory, The Will to Empower shows how democratic citizens and the political are continually recreated.

    • Sales Rank: #501662 in Books
    • Color: White
    • Brand: Brand: Cornell University Press
    • Published on: 1999-05-27
    • Original language: English
    • Number of items: 1
    • Dimensions: 8.99" h x .39" w x 6.03" l, .50 pounds
    • Binding: Paperback
    • 160 pages
    Features
    • Used Book in Good Condition

    Review
    "In her powerful book, Barbara Cruikshank draws on Foucauldian insight with agility and weaves Foucauldian theoretical concerns with empirical studies in supple, jargon-free fashion. The writing is strong and clear, and the argument is bold."―Wendy Brown, University of California, Santa Cruz

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    Jumat, 14 April 2017

    Free PDF Where Did You Sleep Last NightBy Lynn Crosbie

    Free PDF Where Did You Sleep Last NightBy Lynn Crosbie

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    Where Did You Sleep Last NightBy Lynn Crosbie

    Where Did You Sleep Last NightBy Lynn Crosbie


    Where Did You Sleep Last NightBy Lynn Crosbie


    Free PDF Where Did You Sleep Last NightBy Lynn Crosbie

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    Where Did You Sleep Last NightBy Lynn Crosbie

    Does true love have supernatural power?

    Where Did You Sleep Last Night is a love story about a teenage girl who embarks on a relationship with Kurt Cobain.

    Evelyn Gray is a sad and lonely sixteen-year-old from Carnation, Washington who is terrorized by her classmates at school. She spends most of her time in her room reading, writing letters to dead people, listening to old records and talking to the poster of Kurt Cobain above her bed.

    Her mother is an alcoholic grunge relic from Seattle, whose recollections, books and music help ignite Evelyn's love for Cobain-a love so painfully strong that it summons the deceased singer to her side.
    When Evelyn is taken to the hospital after an overdose, she awakens to find Cobain-who has little to no memory of his former life-convalescing in the bed beside her.

    Once united, they quickly become addicted to drugs and each other.

    Cobain-renamed Celine Black-and Evelyn escape the hospital and run off together, determined to have everything they want. Inevitably, they become infamous musicians, but despite their mutual devotion, the couple is tormented by strong passion and jealousy. As their celebrity grows, their relationship becomes more excessive, and an episode of sexual violence explodes, shockingly, into murder.

    A highly original work of haute fan fiction, written in Crosbie's poetic and emotionally evocative prose, Where Did You Sleep Last Night is an imaginative, surprisingly funny, and touching novel about the adamant persistence of love.

    • Sales Rank: #292908 in Books
    • Published on: 2016-09-13
    • Original language: English
    • Number of items: 1
    • Dimensions: 7.90" h x .90" w x 5.20" l, .0 pounds
    • Binding: Paperback
    • 288 pages

    Review
    "The surreal stream of-consciousness Crosbie adopts to describe their drug highs feels remarkably authentic. By turns funny and tragic, fan fiction and elegy, this is a must-read for Nirvana fans. Named for the song popularized by Lead Belly, which Cobain sang in one of his final performances, the novel is just as moving and raw." — Publishers Weekly, Starred Review

    “Lynn Crosbie is what a great writer should be: pissed off, bereft, misunderstood, impolite, funny, and in love with the madness of the world.” — Miriam Toews, author of All My Puny Sorrows

    “Where Did You Sleep Last Night is terrifying and beautiful. It is a thrift store jam packed with once loved, tattered, and gorgeous images. Crosbie is as mad as Rimbaud as sweet as Keats and as debauched as Courtney Love. Kurt Cobain would have adored her.” — Heather O’Neill, author of The Girl Who Was Saturday Night

    “Lynn Crosbie’s Where Did You Sleep Last Night is a brilliant portrait of romance, rages, passionate reunions, the emptiness of fame and the devastating losses that afflict two doomed rock stars locked in a heart-shaped box. Every sentence is poetry. I predict this book will, like Kurt Cobain, develop its own cult following.” — Jowita Bydlowska, author of Drunk Mom

    "Bold, kaleidoscopic, full of absurd black humour, Lynn Crosbie’s new novel Where Did You Sleep Last Night is quite unlike anything else that’s been published recently...It is pop and avant-garde, full of fireworks and heartbreak." — The Globe and Mail

    About the Author
    Lynn Crosbie was born in Montreal and is a cultural critic, author, and poet. A Ph.D in English literature with a background in visual studies, she teaches at the University of Toronto and the Art Gallery of Ontario. Her books (of poetry and prose) include Pearl, Queen Rat, and Dorothy L'Amour. She is also the author of the controversial book, Paul's Case and most recently, Life Is About Losing Everything. She is a contributing editor at Fashion, and a National Magazine Award Winner who has written about sports, style, art, and music.

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    Ebook Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg

    Ebook Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg

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    Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg

    Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg


    Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg


    Ebook Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg

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    Basic Essay Writing: How to write different types of essaysBy Leslie Lynn Schnorenberg

    This writing curriculum is designed to be used as a workbook. Broken down into ten different sections or weeks, students will learn the basics of essay writing. Students will be given instruction and assignments on 8 different types of essays - Descriptive, Narrative, Autobiographical, Informative, Expository, Argumentative, Compare and Contrast, and Cause and Effect. Also included is instruction for a creative book review, a final course exam and a resource section. Student will enjoy the "easy-to-use" format of this writing curriculum.

    • Sales Rank: #473051 in Books
    • Published on: 2013-04-07
    • Original language: English
    • Dimensions: 11.00" h x .39" w x 8.50" l,
    • Binding: Paperback
    • 166 pages

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