Foundations in Quality for the Life Sciences

Quality is critically important to the success of Life Sciences companies. The Foundations in Quality for the Life Sciences Industry provides presents concepts, tools and techniques for real world, on‐the‐job application of quality that is practical for a wide range of organizations. It is targeted for the application of quality in life sciences, including, but not limited to: biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices, and organizations and institutions that devote the majority of their efforts in the various stages of research, development, clinical trials, manufacturing, supply chain management, project management, technology transfer and commercialization.

This course provides an insight into the mindset of Quality along with an overview the concepts, principles and processes/activities involved in Quality Assurance, Quality Control, and Regulatory Compliance within the Life Sciences Industry. Emphasis will be placed on understanding the “business of Biotech; the remit of Global Regulatory Agencies and principles/processes for establishing and enforcing regulation and guidance; Quality management systems, operations and compliance; Quality leadership; Quality Planning; and Careers in the Quality profession. Students will be exposed to a variety of industry experts during the course. Emphasis will also be placed on current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices. Students will gain a practical knowledge of Quality as a scientific discipline.