Building a solid GLP foundation: implementing shared training programs between the QAU and study personnel.

Quality assurance representatives and study personnel are equally responsible for conducting preclinical studies in compliance with good laboratory practices (GLPs). To provide all employees with a solid understanding of GLP requirements we have implemented a system of shared training programs for the quality assurance unit (QAU) and study personnel. Biologists and chemists complete a three-phase training module that encompasses GLP history, roles and responsibilities of the QAU, and QAU procedures specific to Wildlife International, Ltd. Study directors work with experienced QA trainers and are provided mock auditing assignments, including data, reports, and in-process and facility inspections. QA personnel are in turn trained by qualified study personnel in principal scientific concepts, testing guidelines, and study procedures that will be observed when performing in-process inspections and data audits. Also, as permanent positions become available, selected individuals from the QAU may assume responsibilities in various departments as study directors or laboratory supervisors, and study directors may assume responsibilities as quality assurance representatives. At Wildlife International, Ltd., these shared training programs provide a mutual understanding and knowledge of GLP requirements and their application while promoting respect and harmony between the QAU and study personnel.