Introduction to cGMPs

This course describes the importance and purpose of Good Manufacturing Practices (cGMPs) that ensure safe manufacturing of pharmaceutical products and medical devices as well as enforcement by FDA.

Description

Current Good Manufacturing Practices (cGMPs) are specific requirements that help ensure safer manufacturing of pharmaceutical products and medical devices. This course describes the importance, purpose and enforcement of cGMPs by the U.S. FDA. Topics in this course include history, key subparts of the pharmaceutical regulation, procedures, documentation and data integrity, quality system, responsibilities and FDA inspections. After completing this course, learners will be able to recognize basic cGMP requirements and identify the roles and responsibilities of pharmaceutical and medical device manufacturing employees.