September/October 2011
Volume 31, Number 5



    Project Management Best Practices: Improving Schedule Using a Distributed Workforce
    by Mark Albano, Bruce Kane, and Robert Thomas
    This article presents more than a decade of project management learning about distributing a project workforce and the limits and risks of over distribution.
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    The Science of Project Management: Project Controls Systems Integration
    by Frederick Cramer, Susanne Keller, Christopher Law, Thomas Shih, and Britton Wolf
    The article presents the implementation of a suite of software packages that together provide a total Enterprise project management system.
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    Project Management Strategies for Multi-Company Project Teams
    by Mark Mathis
    This article presents methods and tools for successfully managing projects where team members are from multiple and sometimes competing organizations.
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    Industry Interview Series: John Honey, Associate Director of Facilities Engineering, Genentech, Inc.
    by Keith Gibbs
    John Honey provides insight into Genentech’s approach to delivering capital projects and shares his own perspectives on important issues in the field of project management.
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    Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part II
    by Andrew Walsh
    This article discusses how to establish true science-based limits using data from clinical and toxicological studies, a risk-based approach to evaluating cleaning validation data, and guidance on setting statistical process control limits from that data.
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    Fast-Track Life Sciences Projects: When to Use Design-Assist and Why It Works
    by Raj Vora, P.E.
    This article presents strategies to engage in life science projects from a schedule, quality, and budget standpoint – all with “speed to market” in mind.
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    Using Operational Excellence to Meet the New Process Validation Guidance
    by Bikash Chatterjee, Peter Rafa, and Wai Wong
    This article presents a framework for executing the three stages of process validation, employing the philosophies and methodologies of Operational Excellence (OpEx).
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    A Novel Process Analytical Technology Approach to Automated Pharmaceutical Container Closure Integrity Testing
    by Emiliano Niffoi and Andrea Simonetti
    This article provides an overview of Process Analytical Technology (PAT) methodology application to an automated equipment developed for 100 percent Container Closure Integrity Testing (CCIT) of pharmaceutical items.
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    ISPE Update
    - Pharmaceutical Engineering 2010-2011 Article of the Year Finalists - Project Managers as Mediators - Practice What You Preach! The Project Management of the Project Management Good Practice Guide (PM GPG) - State of the Project Management (PM) Community of Practice (COP) - ISPE Meets Industry Demands for Training in Asia Pacific - ISPE Supports Biotech Industry through Partnership with University of Florida
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    Classified Advertising with Advertiser’s Index

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    Online Exclusive Articles

    Global Regulatory News

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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 © 2011 ISPE. All rights reserved.)

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