Content development: a continuing cGMP training program
Abstract:
As a second example of the content of training materials, this chapter discusses continuing current good manufacturing practice (cGMP) training in four sections. The first section reviews statements taken from regulations and guidances about continuing GMP training, made by the US Food and Drug Administration (FDA) and other regulatory bodies. The interpretive nature of these statements, and the role that risk assessment plays in organizational response to gaps (deviations) between the statements and ongoing behavior, are stressed. The second section addresses the topic of individuals who are qualified to deliver the continuing GMP training, presenting two approaches to qualifying ...
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