In the Environmental Safety group at a sponsor company, scientists who conduct GLP field dissipation studies and other complex field studies often serve as the Study Director. The field study phase of a project is often outsourced to a project management firm and selected field contract research organizations (CRO), and the analytical phase to an appropriate laboratory. Registrants/sponsor companies rely upon experts from their internal Quality Assurance Unit to provide periodic audits of the CRO’s that are utilized; we also interact with QA personnel from the field facility, the project management firm, and the analytical laboratory to ensure key study components are monitored and audited. There are challenges associated with meeting all of the requirements for GLP studies, and input from the Quality Assurance team is critical to successfully conduct and complete key scientific studies to support new and existing active ingredients.

Interactions between the study director and quality assurance experts on GLP agricultural field studies: Challenges and bright spots

2019 Fall National Meeting

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.