This course, brought to you by the SQA Learning Foundation, is for GLP auditors from novice to experienced. It is designed to familiarize the trainee with the GLP requirements for SOPs. It will provide a review of common 483s for missing or ineffective SOPs, as well as industry guidance for SOP management. The course will also review SOP lifecycle and distribution. In addition, it will provide technical writing tips to enable the trainee to write and/or review SOPs for increased effectiveness. Finally, it will enable the trainee to perform an audit of an SOP process.
It is delivered on-demand, at your convenience, in 1 module. The 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 the module, passing the quiz with a 70% average or higher, and submitting the course evaluation.
Course Learning Objectives
By the end of this module, you will be able to accomplish the following objectives:
- List the responsibilities designated in the GLPs for SOP management, approval, and maintenance
- Identify which Standard Operating Procedures are required by Good Laboratory Practice regulations, including FDA 21 CFR Part 58.81, EPA 40 CFR Part 160.81, EPA 40 CFR Part 792.81, and OECD Section II 7.4
- Describe the SOP lifecycle and identify the stakeholders for each step in the lifecycle
- Draft SOPs using good technical writing techniques
- Use and manage data collection forms
- Identify GLP violations recently cited on FDA Form 483s regarding use and management of SOPs
- Improve your organization’s SOPs as part of a quality management system
RQAP re-registration credit: 0.25 GLP or non-GCP unit for completion of entire module
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 email@example.com. You have one year from date of purchase to complete the course.