Developing a New Employee Orientation Program for GXP Compliance

This article addresses several issues that emerge in 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 a...

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Bibliographic Details
Published in:Journal of GXP compliance 2009-07, Vol.13 (3), p.82
Main Author: Welty, Gordon
Format: Article
Language:English
Subjects:
Advertising
Compliance
Employee benefits
Employment
Hiring
Mission statements
New employees
Orientations
Performance appraisal
Prescription drugs
Productivity
Regulated industries
Regulatory agencies
Socialization
Succession planning
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Summary:This article addresses several issues that emerge in 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; therefore, NEO is a timely setting for presenting these expectations. This article reviews the employment lifecycle, the comprehensive process every employee goes through from recruitment to separation, and situates NEO in that lifecycle. Next, various features of a typical NEO program are treated. A scenariobased discussion of regulatory overlap is presented, as well as appropriate employee responses. This is followed by an episodic approach to the history of the US Food and Drug Administration. 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. [PUBLICATION ABSTRACT]
ISSN:1552-5791
2150-6590