Transcription of Pharma Change Control - FDAnews
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Pharma Change Control - FDAnews
Pharma Change Control Strategies for Successful Company-Wide ImplementationThe Executive Briefing SeriesFrom the Editors ofCopyright 2013 by Washington Business Information Inc. All rights reserved. The Executive Briefing Series from The Food & Drug Letter (ISSN 0362-6466), is an in-depth analysis of regulations and issues affecting the pharmaceutical and biologics industries. The series is published monthly, 12 issues per year, for $4,995. Photocopying or reproducing in any form, includ- ing electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher s express written permission. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at or call (978) 750-8400.
In order to successfully introduce a change control program, you must have the support of the com-pany’s top managers. The program also needs a corresponding statement for quality management (see Figure 2). Many types of changes affect several regulation areas simultaneously (e.g. GMP requirements,
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