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Featured Articles

January 2011

Alan Schwartz

Supply Chain Oversight is the FDA's Next Area of Concern

by Alan Schwartz
Consultant, mdi Consultants, Inc., and Former Supervisor of Field Operations, USA FDA

The FDA recently stated its intent to stretch its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to take bigger steps toward managing suppliers and tightening up the supply chain. Carmelo Rosa, an FDA compliance officer, explains that "Currently, the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations but it is looking at other options."

Rosa's quote is an interesting statement and if the FDA takes it seriously, it will start a new compliance incentive to shore up our borders and to prevent the entry of "adulterated" devices.

What could the FDA mean by this type of compliance policy?

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Jennifer Stepniowski

Four Common Quality Misconceptions

by Jennifer Stepniowski
Special Project Manager, Pro QC International

For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

Every situation is unique, so it's important to be as knowledgeable as possible regarding the company I'm working with and their respective industry. Whether it's a small business owner, a QA Manager, or a CEO of a large corporation, these initial conversations allow me to customize an action plan that will address the client's needs and concerns.

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Did you know that Health Canada and the FDA have agreed to perform joint third-party inspections? The joint inspections will allow both the FDA and HC to more effectively manage their respective resources and will also reduce the heavy burden of industries which can now prepare for and host one joint-inspection instead of two.
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