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Featured Articles

September 2012


Peter Knauer

Single Sourcing of Critical Components: Strategies for Optimization

by Peter Knauer
Partner Consultant, MasterControl Quality and Compliance Advisory Services

The increase in virtualized or under-resourced biomedical companies has resulted in a dramatic shift in outsourcing components and supplies. Larger companies are also joining this outsourcing trend. Even more profound is the development of reliance on single sourced suppliers, particularly for critical components. While this can be an effective way to improve cost of goods and efficiencies, there are some significant risks associated with this practice. This paper examines these risks and addresses strategies to dispatching or mitigation these concerns.

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Dennis Arter

Corrective and Preventive Action: What's the Difference?

by Dennis Arter
Independent Consultant and Trainer

This is a common question for many people, both inside and outside of the quality community. It periodically appears every few months in virtual discussion groups and electronic bulletin boards. The question is difficult because the concepts have evolved over several decades, without adequate explanation from the core standards and regulations.

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David Ade

Remote Audit: Out of Sight but Not Out of Mind

by David Ade
Customer Success and Reference Manager, MasterControl, Inc.

In life science and other regulated environments, audit is necessary to comply with regulations and to ensure the quality of products. Regulated companies recognise not only the importance of audit, but the value of frequent audits. However, in these economically challenging times, frequent on-site audits can be costly.

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How to Build a Strong Supply Chain Team

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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Did You Know?

MEDTEC Ireland
October 10-11, 2012, Cork, Ireland

RAPS
October 28-29, 2012, Seattle, WA

BARQA
November 7-9, 2012, Manchester, UK

COMPAMED
November 14-16, 2012, Düsseldorf, Germany

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Did you know that the US Congress recently passed measures (with bipartisan support) that will ensure that all medical devices distributed in the United States carry a unique device identifier? According to a recent FDA press release: "A UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety."
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