6 - Content development: a new employee orientation program

Abstract

This chapter addresses the development of a new employee orientation (NEO) program for GXP compliance. There are two major sets of organizational expectations for the workplace performance of a new employee – compliance and productivity expectations. These expectations are operative from the new hire’s first moment on the job, hence NEO is a timely setting for presenting these expectations. This chapter reviews the Employment Life-cycle, the comprehensive process every employee goes through from recruitment to separation, and situates NEO in that life-cycle. Next, various features of a typical NEO program are sketched. Then a scenario-based discussion of regulatory overlap is presented, as well as appropriate employee responses. This is followed by an episodic approach to the history of the FDA. These episodes are employed as illustrations of the process of continuous improvement (i.e., identification of problems (deviations), investigation and root cause analysis, and remediations). Finally, several aspects of the organization of the NEO program are presented, including the necessity to coordinate the program across several departments.