November/December 2010
Volume 30, Number 6



    Risk-Based MES Implementation Using Hazard Analysis and Critical Control Points (HACCP)
    by Tineke Bos, Paul Irving, and Philip Rees
    This article presents the benefits of replacing a paper-based production system with Manufacturing Execution System (MES).
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    Applying GAMP® 5 to Validate an ERP System
    by Stephen R. Ferrell
    This article discusses how the GAMP 5 quality risk management strategy was applied to an actual case study of a validated Enterprise Resource Planning (ERP) system.
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    Scaling of Quality Measures When Using a Configurable Manufacturing Execution System
    by Rolf Blumenthal
    This article focuses on scalability of activities in the life cycle of computerized systems and outlines the level of service standards that pharmaceutical customers can expect from computer system suppliers.
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    Industry Interview Series: Dr. Johannes Roebers, Senior Vice President, Head of Biologic Strategy, Planning and Operation, Elan Pharmaceutical International Ltd.
    by Catherine Middelberg
    Dr. Johannes Roebers provides insight into Elan’s work on current and potential therapies for Alzheimer’s, Parkinson’s, and Multiple Sclerosis and discusses the state of biosimilars today.
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    IT Outsourcing and Offshoring: Recognizing and Managing Risk
    by Arthur D. Perez, PhD and Glenn Morton
    This article discusses risks and mitigation strategies that need to be considered between healthcare companies and outsourced IT suppliers.
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    Global Regulatory News

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    ISPE Update
    - Discovering the True Value of Membership - GAMP Documents Update - PQLI Update from Brussels: Case Studies in QbD for Biotechnology and Small Molecule Product Realization - Introducing the 2010-2011 Board of Directors - What is the CPIP Certification and What are the Benefits? - Pharmaceutical Engineering Announces Winner of the Article of the Year Award
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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    Prevent Counterfeiting in the Pharmaceutical Industry
    by Janice Abel
    Many companies now deploy specialized packaging, applications, and other anti-counterfeiting technologies to help prevent counterfeit products, protect brands, protect customers, and allow rapid and effective response to counterfeit products. ARC would be interested to learn what steps, if any, your company takes.
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    2010 Scope of Practice & Compensation Report for the Regulatory Profession
    Regulatory Affairs Professionals Society (RAPS)
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    NOTE: Pharmaceutical Engineering article PDF documents are not to be posted on any Web site, blog site or page, or any other internet site without prior permission from ISPE. (Copyright © 2010 ISPE. All rights reserved.)

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