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A Healthy Step: Applying GMPs to Dietary Supplements” by Ed Tannebaum, Chuck Stock and Andy DeFilice, Nutritional Outlook, Vol. 11, Issue 1, January/February 2008
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Development Knowledge Can Increase Manufacturing Capability and Facilitate Quality by Design by Russ Somma, Ph.D., Journal of Pharmaceutical Innovation, December 2007 issue
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White Paper: "Current Trends in Sterile Manufacturing", Sterling Kline, RA
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“Energy Savings in Pharmaceutical Facilities: A Risk-Based Approach” by Dave Goswami, PE and Mark Butler, Pharmaceutical Engineering, November/December 2007
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Read Expert Insight by Steve Wisniewski and Chuck Stock, CxA: “Implementing the ASTM standard for verification: Standard’s key objective is to give industry-wide flexibility
regarding implementation”, CleanRooms, October 2007
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Russ Somma, PhD offers Using Technology Transfer to Maximize Business Efficiency”, Pharmaceutical Engineering, September/October 2007
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A Technology Viewpoint: “Aspects of Non-Invasive Drug Therapy” by Russ Somma, PhD, LifeSciTech, Q3 2007
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“Operation Excellence: Leveraging Lean Techniques”, by Mike Gadway and Rafi Maslaton, LifeSciTech, Q4 2007
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Biotech Expert, Paul Miraglia, quoted in "Designing Out Up & Downstream Mismatches", Genetic Engineering & Biotechnology News, Volume 27, Number 7, April 1, 2007
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IPS Subject Matter Expert, John Gilroy, PE, quoted in "Injectable Drugs: New Candidates, New Formulations and New Delivery Vehicles", Pharmaceutical Commerce, April 2007
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IPS Expert Sterling Kline, RA quoted in CleanRooms, Volume 21, No. 4m April 2007, "Barrier and Isolation Systems: Technology in Transition"
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more>>
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Isolator Technologies Slowly Catching On
IPS Expert Sterling Kline quoted in Genetic Engineering News, "Isolator Technologies Slowly Catching On"
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more>>
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Cost Effective cGMP Facilities
This article presents cost saving opportunities for engineers to consider as they
conceive, design and construct.
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more>>
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Design/Build Project Delivery
Method: Strategic Opportunities for
Pharmaceutical Facilities
Alternative project delivery
systems are proving their effectiveness to reduce cost and time on GMP
facilities.
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more>>
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Good Commissioning Practices:
Strategic Opportunities for Pharmaceutical
Manufacturing
This article identifies opportunities
to improve project delivery through application of better project
management techniques.
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more>>
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Regulatory Compliance
Leads to Improved Process
Process industries continue to
devote significant resources to meet compliance obligations due to the tremendous growth in
government regulation.
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more>>
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Pharmaceutical Facility Cost: Variances,
Categories, and Causes
Pharmaceutical facility costs vary dramatically
from building to building. This article examines the causes and origins of the
cost fluctuations.
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more>>
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Strategic Project Management: Trends and
Opportunities in Pharmaceutical Manufacturing
This article identifies major strategic issues and reviews implications for the
industry with particular attention to
manufacturing and project management.
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more>> |