Quality Regulations and Standards for Biotechnology
This course will cover the history of quality systems (cGMP, GLP, GCP, ISO 9000) and their implementation in the workplace. Emphasis will be placed on the impact of these quality systems on the laboratory technician. Students will also have the opportunity to study regulations and examine the process of disciplinary action under these systems. Current case studies will illustrate the role of governmental and non-governmental oversight in ensuring the quality of the products of regulated workplaces.