No training program is complete without a solid core of comprehensive courses. Good Laboratory Practice (GLP) online training courses from OverNite Software, inc. will help your team easily and conveniently navigate the federal requirements and international guidance for nonclinical laboratory studies.
Professional content, graphics, animations, and narration are the hallmarks of OverNite Software courses. Courses are structured in an easy-to-understand format with stated objectives, multiple lessons, and feedback screens requiring the learner to revisit content if they answer a test question incorrectly.
Our courses are delivered via ExxTend Learning™, a versatile learning management system that allows you to adjust testing parameters, use pre-tests, and even customize courses with site-specific content and photos.
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. (60 min)
Is an overview course that explains GLP and its purpose. The course also examines GLP regulations and the fundamentals of GLP. (20 min)
Explores the required resources for a nonclinical laboratory study conducted according to GLP. Personnel, facilities, and equipment are discussed in detail. (20 min)
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. (20 min)
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. (25 min)
Provides an overview of the characterization, special handling, and documentation requirements for test articles, control articles, and test systems. (30 min)
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. (25 min)
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. (30 min)