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Featured Articles

July 2010


Brian Curran

Automating Training Control Processes for Compliance

Brian Curran
SVP, Strategic Marketing & Product Management, MasterControl, Inc.

FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training (21 CFR 211.25 and 820.25). These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This article identifies the basis for the requirements and examines the associated challenges for meeting those requirements. In addition, this article discusses the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking of requirements is presented.

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Mark Kaganov

ISO 9001: Quality Objectives and Quality Dreams

Mark Kaganov
Director of Quality Operations, Quality Works

This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. Kaganov, the Director of Quality Operations at Quality Works, suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. The ineffectiveness that results from vague and poorly defined quality objectives will be demonstrated; it will also be shown that well-structured and documented quality objectives can lead to a more efficient quality management system that increases customer satisfaction. An example of a Quality Objectives Matrix (shown in the article) presents a useful method for documenting and managing various aspects of quality management systems.

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Michael J. Gregor

Computer System Validation: FDA Inspections

Michael J. Gregor
President, Compliance Gurus, Inc.

Is your organization ready for an inspection of your Computer System Validation program? In this article, Michael Gregor, President of Compliance Gurus, offers 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 the 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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For many organizations the Internet has provided an avenue for increased transparency. The FDA for example—according to FDANews and Drug Industry Daily—is planning to post adverse event evaluations online. The adverse event information will be updated on a quarterly basis and will include summary analyses. Related literature and sources will also be published.
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