This course will provide an introduction to the concepts and requirements for global pharmaceutical quality and regulatory compliance. The development of international harmonization for drug development and manufacture has made expert knowledge of these areas essential for pharmaceutical engineers and other professionals. The ICH guidelines have mandated a quality by design approach for drug development on continuous improvement as a goal of the quality system within organizations. Quality by Design, Process Analytical Technology (PAT) and Critical Quality Attributes (product and process) were introduced by the regulatory agencies (FDA) to provide the foundation for ensuring that product quality, safety and efficacy are built into process during design and not introduced as an afterthought. This introductory course provides the basic principles of QBD, PAT and CQAs using case studies and definition and terms relevant to understanding how a modern biopharmaceutical products are developed and marketed in a highly regulated environment.
MEng program students only