IMPLEMENTING A GOOD LABORATORY PRACTICE TRAINING PROGRAM FOR REGULATORY PERSONNEL

Abstract

The purpose of this project was to develop a Good Laboratory Practice (GLP) training program for regulatory personnel. By developing and implementing such a training program, it was expected that personnel would be able to apply these regulations while auditing GLP final reports. Three separate training modules were created, each consisting of a Microsoft® PowerPoint® slide presentation, a warning letter for review, background information related to the GLPs, and a post-test. After all training modules were completed, a representative GLP final report was distributed for audit. Although test scores were passing after each training module and the training was well received, personnel were inconsistent in conducting the audits and in determining compliance to the GLPs. Future planning and training will focus specifically on auditing GLP final reports.