This course, brought to you by the SQA Learning Foundation, is designed for anyone needing to learn about GLP regulations, including, but not limited to: QA Personnel (GLP Auditors), Study Directors, Principal Investigators, Management, Scientists, Technicians, Facilities Personnel, and Archivists, with 0-2 years or more of experience. This course intends to equip the participant with a working knowledge of GLP impacts on study conduct through a thorough examination of the basics of the history of the FDA GLPs and the regulations. There are periodic comparisons with EPA GLPs as well. It provides excellent GLP Basic or refresher training for all personnel involved in a nonclinical laboratory study. It is delivered on-demand, at your convenience, in 11 modules. Each module will deliver information to you, let you self-assess your knowledge with review questions interspersed throughout the module, and will culminate with a quiz at the end of the module. You will be able to access the course certificate after completing all of the modules, passing each module quiz with a 70% average or higher, and submitting the course evaluation. For the modules included in this course, please see the list below. For the learning objectives for the modules, please click here.
- Module 1: History of GLPs
- Module 2: Subpart A: General Provisions
- Module 3: Subpart B: Organization and Personnel
- Module 4: Subpart C: Facilities
- Module 5: Subpart D: Equipment and Computer Systems
- Module 6: Subpart E (Part 1): Test Facility Operations - SOPs and Reagents/Solutions
- Module 7: Subpart E (Part 2): Test Facility Operations - Animal Care
- Module 8: Subpart F: Test and Control Articles
- Module 9: Subpart G (Part 1): Protocols for Nonclinical Studies
- Module 10: Subpart G (Part 2): Conduct of a Nonclinical Study
- Module 11: Subpart J: Records and Reports
RQAP re-registration credit: 3.38 GLP or non-GCP units for completion of all 11 modules.
Policies: No refunds will be provided for this course under normal circumstances; under extenuating circumstances, the SQA Board of Directors may consider individual requests for refunds made in writing to firstname.lastname@example.org. You have one year from date of purchase to complete the course.