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Introduction to Regulatory Affairs in Manufacturing
University of Galway - Direct Enroll Program
Galway, Ireland
Dates: late Aug 2025 - mid Dec 2025
Introduction to Regulatory Affairs in Manufacturing
OVERVIEW
CEA CAPA Partner Institution: University of Galway
Location: Galway, Ireland
Primary Subject Area: Mechanical Engineering
Other Subject Area: Engineering
Instruction in: English
Course Code: ME3104
Transcript Source: Partner Institution
Course Details: Level 300
Recommended Semester Credits: 2.5
Contact Hours: 36
DESCRIPTION
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.
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.