Pharmaceutical Quality Assurance and Regulatory Affairs Online Course & Certificate

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:

• Overview of quality control and assurance
• Good Manufacturing Practice (GMP)
• Regulatory agencies
• Documentation

No prior experience or coursework required. 

 Students will be assigned 5 homework assignments, and 1 final exam. 

• Introduction to Quality Control and Quality Assurance
• Functions of Quality Control Department
• Regulatory Compliance
• Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
• The FDA’s Approach to GMP Inspections of Pharmaceutical Companies
• Quality and compliance auditing
• Documentation systems
• Standard Operating Procedures (SOPs)
• Food, Drug and Cosmetic Acts Regulations
• International Conference on Harmonization (ICH) Guideline for QA
• Drug stability studies according to USP / ICH

 This course is Instructor-led and delivered through our award-winning online Learning Management System.