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Qualification of Employees for GXP Compliance
Author: Gordon Welty

The US Food and Drug Administration requires all employees who work in controlled areas to be trained. FDA provides latitude for organizations in regulated industry to develop their own training systems to ensure that employees are appropriately trained for GXP compliance. This article focuses on the topic of employee qualification, a critical kind of training in regulated industry. It further provides a comprehensive framework for an organizational approach to employee qualification. A typology of training is presented. Specific employee qualification considerations, including employee qualification as process, qualification status, and measures to demonstrate qualification are discussed. Employee qualification should be based on a complexity and criticality assessment. These concepts demonstrate an organized approach to employee qualification, compliant with regulatory requirements and expectations, and consistent with modern principles of risk analysis.

This is the third of a series of articles on the development of a GXP training system. The first was “Developing a New Employee Orientation Program for GXP Compliance,” Journal of GXP Compliance, Vol. 13, No. 3 (Summer 2009), pp. 82-92. The second was “Developing a Continuing CGMP Training Program,” Journal of GXP Compliance, Vol. 13, No. 4 (Autumn 2009), pp. 86-96.

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