Quality assurance and control measures are mandated both by the development company and by regulatory agencies to ensure product identity, purity and safety. This course presents the regulations set forth by regulatory agencies with emphasis on the FDA model. We also introduce Good Manufacturing Practice criteria and reviews Quality Assurance and Quality Control functional responsibilities. After completing Pharmaceutical Quality Assurance & Regulatory Affairs, students will be equipped with a basic understanding of the following: No prior experience or coursework required. No prerequisites are required. Students will be assigned 5 homework assignments, and 1 final exam for each course. This course is Instructor-led and delivered through our award-winning online Learning Management System.
