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Final Implementation of the Training Module

The seventh in a series report on training and the ADDIE Model is presented. In the pharmaceutical, biopharmaceutical, medical device, blood product, and other US Food and Drug Administration regulated industries, the need for optimal delivery of the training is constrained by the requirement that e...

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Bibliographic Details
Published in:Journal of GXP compliance 2009-04, Vol.13 (2), p.67
Main Author: Welty, Gordon
Format: Article
Language:English
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Summary:The seventh in a series report on training and the ADDIE Model is presented. In the pharmaceutical, biopharmaceutical, medical device, blood product, and other US Food and Drug Administration regulated industries, the need for optimal delivery of the training is constrained by the requirement that employees be trained before they are assigned to "touch" the product. Each and every employee impacted by a new or revised procedure must be trained. This article examines that problem and considers several approaches to addressing it. First, it will review the scope and impact of the FDA regulations for pharmaceutical manufacturing in general, and about training in particular. Next, it will critically examine several approaches to ensuring that employees are trained before they touch the drug product, and find that each has shortcomings. Third, it will propose an alternative approach that facilitates the communication necessary to ensure the requisite training has taken place in a timely fashion.
ISSN:1552-5791
2150-6590