Introduction to Regulatory Affairs in Manufacturing University of Galway - Engineering & Computer Science Program Fall 2022 Semester - Galway

Safe Product Design, medical device directive, FDA regulations & GMP, medical device risk assessment, machinery directive, Risk management.

Learning Outcomes
1.Understand and state the role of Regulatory Affairs in business from a product design, approval and process perspective, specifically the EU MDD and US FDA regulations.
2.State the concepts of Good Manufacturing Practice(cGMP), Corrective and preventive action(CAPA) as applied to a regulated manufacturing environment such as medical device manufacturing.
3.State product safety and regulatory requirements and develop a product liability prevention programme.
4.State the requirements of the EU machinery directive and be able to apply them to a machinery manufacturer and be able to carry our relevant risk assessments.
5.Carry our risk assessment and risk management activities as required to support product and process design.