Upon completion of this training, you will be able to: • Define the who, why and how of a Pharmaceutical Quality System (PQS) • Describe the Benefits, elements, composition and how to implement an effective Quality Management Systems (QMS) • Explain the requirements of Product Quality Review and Quality Risk Management • Describe the five (5) segments and Contents of ICH Q10: Pharmaceutical Quality System • Define Management responsibilities, Continual Improvement of Process Performance, Product Quality and Pharmaceutical Quality System.