Abstract

This chapter will begin the discussion of the role of training in ensuring compliance with current manufacturing practices, and in particular, current good manufacturing practices (cGMPs). It is convenient to present the role of training in terms of the program improvement model. This model provides guidance at a fairly high level for program developers, instructional designers, software engineers, etc. as they author and revise their products. There are several application values of the program improvement model. First, the model clarifies and standardizes the process of addressing performance gaps in an organization, allowing best practices to be identified and implemented. Second, this model is widely utilized in various forms in the pharmaceutical industry, which facilitates benchmarking of program development initiatives between organizations.

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