ABSTRACT
This chapter highlights how combining compliance requirements and performance needs provide not only an effective training strategy for those engaged in drug development, but also a robust process for ensuring a successful Pre-approval inspections. It outlines the need for an effective training strategy with associated training requirements; the need for a performance-based training approach within this training strategy; and regulatory requirements for training during the development process. The training strategy must clearly outline the necessary training requirements. A successful training strategy goes beyond merely training individuals; it ensures that these individuals are qualified. The training strategy must align curricula to these duties accordingly, through the use of duty-aligned curricula assignments. The training strategy should contain requirements regarding acceptable performance and continued qualification. A successful training strategy must include a plan to address insufficient performance that results in disqualification. The pharmaceutical industry exists in an environment of continued flux, including changing regulatory requirements, economic conditions, and patient needs.
