...1. Difference between prospective validation, retrospective validation and revalidation. Prospective Validation * Carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps * These are then evaluated on the basis of past experience to determine whether they might lead to critical situations * Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. * The trials are then performed and evaluated, and an overall assessment is made * If, at the end, the results are acceptable, the process is satisfactory. Unsatisfactory processes must be modified and improved until a validation exercise proves to be satisfactory. * This form of validation is essential in order to limit the risk of erors occurring on the production scale, eg. In the preparation of injectable products. Retrospective Validation * Retrospective Validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged * Such experience and the results of in-process and final control tests are then evaluated * Recorded difficulties and failures in production are analyzed to determine the limits of process parameters. * Retrospective Validation is obviously not a quality assurance...
Words: 652 - Pages: 3
...Technology and Health Care 19 (2011) 483–495 DOI 10.3233/THC-2011-0646 IOS Press 483 Rehabilitation Engineering Rehabilitation robotics Marko Munih and Tadej Bajd∗ Faculty of Electrical Engineering, University of Ljubljana, Slovenia Abstract. The paper presents the background, main achievements and components of rehabilitation robotics in a simple way, using non-technical terms. The introductory part looks at the development of robotic approaches in the rehabilitation of neurological patients and outlines the principles of robotic device interactions with patients. There follows a section on virtual reality in rehabilitation. Hapticity and interaction between robot and human are presented in order to understand the added value of robotics that cannot be exploited in other devices. The importance of passive exercise and active tasks is then discussed using the results of various clinical trials, followed by the place of upper and lower extremity robotic devices in rehabilitation practice. The closing section refers to the general importance of measurements in this area and stresses quantitative measurements as one of the advantages in using robotic devices. Keywords: Robot, haptic interface, virtual reality, measurement 1. Introduction The application of robotic approaches in neurological patient rehabilitation was introduced almost two decades ago [1]. Even though the number of robotic rehabilitation systems is large, the number of clinical trials remains quite...
Words: 6470 - Pages: 26
...Rehabilitation of Acromioclavicular Joint Separations: Operative and Nonoperative Considerations Mark P. Cote, PT, DPTa, Karen E. Wojcik, MSPT, ATCb, Gregg Gomlinski, MSPT, CSCSb, Augustus D. Mazzocca, MS, MDa,* Acromioclavicular joint (AC) separations are one of the most common injuries seen in orthopedic and sports medicine practices, accounting for 9% of all injuries to the shoulder girdle.1–3 Various operative and nonoperative treatment schemes have been described for the management of AC joint injuries.4–33 Although considerable controversy exists over the efficacy of surgical reconstruction versus nonoperative intervention for grade III type injuries, grade I and II separations seem to respond favorably to conservative management. Conversely, grades IV, V, and VI often require surgical reconstruction. Regardless of the type of injury, rehabilitation as a part of conservative management and postoperative care plays an important role in the management of these injuries. This article presents the authors’ rehabilitation approach to treatment of acromioclavicular separations pre- and postoperatively. CONCEPTUAL FRAMEWORK To provide instruction and insight for rehabilitation clinicians, protocols are often provided for a specific injury or procedure. A protocol is a system of rules or procedures for a given situation. Although intended to be informative, protocols often result in a restrictive list of exercises and arbitrary time frames that a clinician...
Words: 5903 - Pages: 24
...2011 Inter/Summer Course Offerings (Tentative) Course Section Credits Act Days Start Time Stop Time Bldg/Room February 27, 2011 10:14:21AM Professor Page 1 Exam Time General Arts 12-WEEK SESSION 0101-150 Section 1 Foundations of Academic Writing I 3.00 LEC TBA This is an on-line only course, all Exams on campus. You will be notified via your UWIN email address regarding how to get started in the course. It is also posted on CLEW. You may also click on the link for your course and section number for further information. Mandatory orientation sessions will be held. Foundations of Academic Writing II 3.00 LEC TBA This is an on-line only course, all Exams on campus. You will be notified via your UWIN email address regarding how to get started in the course. It is also posted on CLEW. You may also click on the link for your course and section number for further information. Mandatory orientation sessions will be held. 3.00 LEC TBA Section Offered as an On-Line Only Course Reserved for Engineering students only. This course section is designed to develop effective writing skills for communicating ideas in academic and other tasks, as a follow up to 01-01-150. Topics will include a cursory review of grammar, writing processes, and conventions of different technical writing forms which engineers are expected to use in both the classroom and workplace. The main content of the course consists of introductory concepts of technical writing, business correspondence, various...
Words: 12892 - Pages: 52
...TENNIS RECOVERY A Comprehensive Review of the Research Editors: Mark S. Kovacs, PhD Todd S. Ellenbecker, DPT W. Ben Kibler, MD A United States Tennis Association Sport Science Committee Project Tennis Recovery: A Comprehensive Review of the Research Copyright © 2010 United States Tennis Association Inc. ISBN 978-0-692-00528-6 Editors: Mark S. Kovacs, Todd S. Ellenbecker, W. Ben Kibler TENNIS RECOVERY A Comprehensive Review of the Research A United States Tennis Association Sport Science Committee Project Editors: Mark S. Kovacs, PhD Todd S. Ellenbecker, DPT W. Ben Kibler, MD Introduction In the last two decades, physical training and competitive opportunities have increased dramatically in junior, collegiate and professional tennis. This arose due to a multitude of factors, but much of it has stemmed from an increase in knowledge and understanding of scientifically based training programs focused on improving performance. As this focus on performance has increased, the area of recovery has received relatively limited focus. Recovery is a multi-faceted paradigm focusing on recovery from training—session to session, day to day and week to week. Recovery is also vitally important during training as well as in competition between matches and between days during multi-day tournaments. As more information is needed in the area of tennis specific recovery, the Sport Science Committee of the United States Tennis Association (USTA) sponsored an extensive evidence-based...
Words: 64903 - Pages: 260
...STUDENTS’ CONSTRUCTION OF THE BODY IN PHYSICAL EDUCATION A Dissertation Submitted to the Graduate Faculty of the Louisiana State University and Agricultural and Mechanical College in partial fulfillment of the Requirements for the degree of Doctor of Philosophy in The Department of Kinesiology by Laura Azzarito B.S., Universita’ di Scienze Motorie di Torino, Italy, 1994 M.S., University of Maryland, College Park, 2000 December 2004 ACKNOWLEDGEMENTS I’m very grateful to all the students and teachers who are the subjects of this work. I greatly appreciate their willingness to participate in this research and the time they dedicated to all of the interviews and member checks. I also thank the principals who gave me permission to conduct this study. I especially acknowledge and thank physical education teachers Celeste Alfred, for welcoming me to her school, and Vickie Braud for her great help in making contacts necessary to complete my data collection. Both Vickie and Celeste were wonderful throughout my research process, helping me to observe classes and arrange student interviews at the schools. I greatly appreciate all the suggestions, insights and comments of my committee members. Thank you to all of them: Dr. Kuttruff, my external committee member, for her interest in following the steps of my dissertation; Dr. Magill, for bringing a very challenging and valuable perspective to my research; Dr. Lee, for her deep knowledge and expertise in the field of physical education;...
Words: 64949 - Pages: 260
...McGraw-Hill Create™ Review Copy for Instructor Espinoza. Not for distribution. Course BBE 4505 Omar Espinoza University Of Minnesota NATURAL RESOURCES McGraw-Hill Create™ Review Copy for Instructor Espinoza. Not for distribution. http://create.mcgraw-hill.com Copyright 2012 by The McGraw-Hill Companies, Inc. All rights reserved. Printed in the United States of America. Except as permitted under the United States Copyright Act of 1976, no part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without prior written permission of the publisher. This McGraw-Hill Create text may include materials submitted to McGraw-Hill for publication by the instructor of this course. The instructor is solely responsible for the editorial content of such materials. Instructors retain copyright of these additional materials. ISBN-10: 1121789048 ISBN-13: 9781121789043 McGraw-Hill Create™ Review Copy for Instructor Espinoza. Not for distribution. Contents 1. Preface 1 2. Methods, Standards, and Work Design: Introduction 7 Problem-Solving Tools 27 3. Tex 29 4. Operation Analysis 79 5. Manual Work Design 133 6. Workplace, Equipment, and Tool Design 185 7. Work Environment Design 239 8. Design of Cognitive Work 281 9. Workplace and Systems Safety 327 10. Proposed Method Implementation 379 11. Time Study 413 12. Performance Rating and Allowances 447 13. Standard Data and Formulas 485 14. Predetermined Time Systems 507...
Words: 294686 - Pages: 1179
...fourth EDItION fourth EDItION This clear, learner-friendly text helps today’s students bridge the gap between Its comprehensiveness allows instructors to tailor the material to their individual teaching styles, resulting in an exceptionally versatile text. Highlights of the Fourth Edition: Additional readings and essays in a new Appendix as well as in Chapters 7 and 8 nearly double the number of readings available for critical analysis and classroom discussion. An online chapter, available on the instructor portion of the book’s Web site, addresses critical reading, a vital skill for success in college and beyond. Visit www.mhhe.com/bassham4e for a wealth of additional student and instructor resources. Bassham I Irwin Nardone I Wallace New and updated exercises and examples throughout the text allow students to practice and apply what they learn. MD DALIM #1062017 12/13/09 CYAN MAG YELO BLK Chapter 12 features an expanded and reorganized discussion of evaluating Internet sources. Critical Thinking thinking, using real-world examples and a proven step-by-step approach. A student ' s Introduction A student's Introduction everyday culture and critical thinking. It covers all the basics of critical Critical Thinking Ba ssha m I Irwin I Nardone I Wall ace CRITICAL THINKING A STUDENT’S INTRODUCTION FOURTH EDITION Gregory Bassham William Irwin Henry Nardone James M. Wallace King’s College TM bas07437_fm_i-xvi.indd i 11/24/09 9:53:56 AM TM Published by McGraw-Hill...
Words: 246535 - Pages: 987
...fourth EDItION Critical Thinking A student ' s Introduction Ba ssha m I I rwi n I N ardon e I Wal l ac e CRITICAL THINKING A STUDENT’S INTRODUCTION FOURTH EDITION Gregory Bassham William Irwin Henry Nardone James M. Wallace King’s College TM TM Published by McGraw-Hill, an imprint of The McGraw-Hill Companies, Inc., 1221 Avenue of the Americas, New York, NY 10020. Copyright © 2011, 2008, 2005, 2002. All rights reserved. No part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written consent of The McGraw-Hill Companies, Inc., including, but not limited to, in any network or other electronic storage or transmission, or broadcast for distance learning. This book is printed on acid-free paper. 1 2 3 4 5 6 7 8 9 0 DOC/DOC 0 ISBN: 978-0-07-340743-2 MHID: 0-07-340743-7 Vice President, Editorial: Michael Ryan Director, Editorial: Beth Mejia Sponsoring Editor: Mark Georgiev Marketing Manager: Pam Cooper Managing Editor: Nicole Bridge Developmental Editor: Phil Butcher Project Manager: Lindsay Burt Manuscript Editor: Maura P. Brown Design Manager: Margarite Reynolds Cover Designer: Laurie Entringer Production Supervisor: Louis Swaim Composition: 11/12.5 Bembo by MPS Limited, A Macmillan Company Printing: 45# New Era Matte, R. R. Donnelley & Sons Cover Image: © Brand X/JupiterImages Credits: The credits section for this book begins on page C-1 and is considered...
Words: 240232 - Pages: 961