7 - 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 trainers – a formal approach such as a GMP train-the-trainer (TTT) program and an experiential approach. While the experiential approach is cheaper than the formal approach, the formal approach has the merit of reducing variation in employee performance, as well as facilitating root cause analysis (RCA) in case of deviations. The third section reviews major sources of topics that are available for continuing cGMP training, including regulations in 21 CFR 211, written procedures required by these regulations, and topics mentioned in FDA guidances, FDA warning letters, and the organization’s own records of deviations, investigations, corrective actions and preventive actions, and quality complaints. The final section reviews a major logistical issue in the delivery of continuing cGMP training: the frequency with which this training should be scheduled. FDA recommends training more frequently than just on an annual basis.