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Featured Articles

May 2010

Tips for Avoiding Internal and External Supplier Problems

Seth Mailhot

The signing of the historic healthcare reform legislation will have a significant impact on both the medical device and pharmaceutical industries. A significant increase in the number of individuals carrying health insurance will translate into a greater demand for medical devices and pharmaceuticals. While this will improve profitability for many companies, it will present challenges to manufacturing and quality managers tasked with finding ways to quickly increase production.

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Computer System Validation: FDA Inspections

Michael J. Gregor

Is your organization ready for an inspection of your Computer System Validation program? In this article, I will offer some key tips on how to prepare for an inspection of your computer system validation (CSV) program. Often times, the FDA comes to inspect your facility for reasons other than your CSV program. However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, investigators are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

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How Auditing Supports Supply Chain Management

Dennis Arter

One of the fundamental rules of auditing is to measure and evaluate against requirements. While requirements come from multiple sources in an internal and registration audit, for supplier audits these requirements always come from the contract. (Contracts come in a number of different forms, such as purchase orders, letter agreements, etc.) Three things need to be considered, when writing a supplier contract: technical requirements, accept-reject criteria and/or management system requirements.

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ASQ World Quality
May 24-26, 2010, St. Louis, MO

MD&M East 2010
June 7-10, 2010, New York, NY

Quality Event Management CAPA Training
June 16-17, 2010, Chicago, IL

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September 15-16, 2010, Newport Beach, CA

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