The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
Informations légales : prix de location à la page 0,5250€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.
Extrait
Mastering and Managing the FDA Maze, Second Edition
Also available from ASQ Quality Press
Quality Risk Management in the FDA-Regulated Industry José Rodríguez-Pérez
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition Amiram Daniel and Ed Kimmelman
Statistical Process Control for the FDA-Regulated Industry Manuel E. Peña-Rodríguez
CAPA for the FDA-Regulated Industry José Rodríguez-Pérez
Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition Elaine Whitmore
Medical Device Design and Regulation Carl T. DeMarco
The Quality Toolbox, Second Edition Nancy R. Tague
Root Cause Analysis: Simpliîed Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug
The Certiîed Manager of Quality/Organizational Excellence Handbook, Fourth Edition Russell T. Westcott, editor
The Certiîed Six Sigma Black Belt Handbook, Second Edition T.M. Kubiak and Donald W. Benbow
Root Cause Analysis: The Core of Problem Solving and Corrective Action Duke Okes
To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at http://www.asq.org/quality-press.
Mastering and Managing the FDA Maze, Second Edition
Medical Device Overview
A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
Library of Congress Cataloging-in-Publication Data
Harnack, Gordon, 1939– author. Mastering and managing the FDA maze: medical device overview: a training and management desk reference for manufacturers regulated by the Food and Drug Administration/Gordon Harnack. — Second edition. p.; cm. Medical device overview Includes bibliographical references. ISBN 978-0-87389-887-4 (softcover: alk. paper) I. American Society for Quality, issuing body. II. Title. III. Title: Medical device overview. [DNLM: 1. United States. Food and Drug Administration. 2. Equipment Design—United States. 3. Equipment and Supplies—United States. 4. Equipment Safety—methods—United States. 5. Government Regulation—United States. 6. United States Government Agencies—organization and administration—United States. W 26] KF3827.M4 344.7304’1--dc23 2014015434
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Acquisitions Editor: Matt T. Meinholz Managing Editor: Paul Daniel O’Mara Production Administrator: Randall Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.
To place orders or to request ASQ membership information, call 800-248-1946. Visit our Web site at www.asq.org/quality-press.