Explores the FDA regulation 21 CFR 58 (Good Laboratory Practice for Nonclinical Studies) and two similarly applicable EPA regulations (40 CFR 169 and 40 CFR 792). This course also addresses OECD principles, the international counterpart to U.S. regulations.
Is an overview course that explains GLP and its purpose. The course also examines GLP regulations and the fundamentals of GLP.
Explores the required resources for a nonclinical laboratory study conducted according to GLP. Personnel, facilities, and equipment are discussed in detail.
Examines the responsibilities mandated by 21 CFR 58 as they apply to testing facility management, the study director, study personnel, and the quality assurance unit. The responsibilities of the study sponsor are also discussed.
Examines the conduct of nonclinical laboratory studies according to 21 CFR 58 with special attention to the purpose and use of protocols and standard operating procedures.
Provides an overview of the characterization, special handling, and documentation requirements for test articles, control articles, and test systems.
Explains how to prepare for a data audit by creating compliant records. This course discusses how to compile these records into a final report for submission to the FDA and how these records must be archived.
Explains which records fall under 21 CFR Part 11 (also known as Part 11), the characteristics that electronic records must have to be acceptable, and how to control computer systems used to manage electronic records. The course also discusses the types of electronic signatures that are acceptable and the safeguards that must be used so that they will be non-refutable.