The Regulatory Environment

This course promotes all aspects of quality control, awareness and adherence to quality guidelines and regulations, with a focus on accuracy and safety in all aspects of bioscience work. It examines the need for health and safety regulations and the use of risk assessments to ensure the best possible understanding of the contexts within which scientists operate and how to mitigate accidents.

Learners will examine the internal and external regulatory environment pertinent to the bioscience and health sectors, for example Medicines & Healthcare Products Regulatory Authority (MHRA), Control of Major Accident Hazards (COMAH), Control of Substances Hazardous to Health (COSHH), Good Laboratory Practice (GLP) and Good Manufacturing Practice.