Lectures will present an overview of Good Laboratory Practice Standards (as defined by the EPA, 40 CFR Part 160 of the Federal Register, and the FDA, 21 CFR Part 58 of the Federal Register) for conducting acceptable regulatory laboratory studies in support of both pesticide and drug registrations. The course includes exercises in the evaluation of protocols, using SOPs for the preparation of standard solutions and the rejection of data, and the evaluation of laboratory labels. Students will gain a broad understanding of the requirements reinforced by class exercises for conducting acceptable FDA and EPA studies.
