Quality Systems Approach
This course explains FDA’s guidance on a modern quality systems approach to pharmaceutical manufacturing. Topics in this course include: FDA’s Approach, Quality Concepts, FDA Compliance, Quality System Model, Management Responsibilities, Resources, Manufacturing Operations, and Evaluation Activities. After completing this course, learners will be able to identify the guidance that FDA has provided on quality systems, the ways in which this supports cGMP compliance, and the ways in which the application of a quality systems approach encourages the use of modern quality management principles and promotes innovation and continuous improvement.
After this course learners will be able to identify fda’s guidance on modern quality systems and recognize how this can foster gmp compliance, innovation, and continuous improvement in the manufacture of pharmaceuticals.