Risk Management
Description
This module will provide an understanding of how risks are identified, quantified, evaluated, monitored and controlled in order to meet quality and regulatory requirements, including those in medical devices and pharmaceuticals.
Learning Outcomes
Interpret the regulations/standards relating to Risk Management (including ISO 31000, ISO 14971 and ICH Q9).
Examine the processes of Risk Management Planning, Communication and Review.
Apply risk assessment tools and techniques such as Hazard Analysis and FMEA to Identify, quantify and evaluate hazards and risks in design, systems and processes.
Review the acceptability of assessed risks, instigate mitigation to control/remove risk, and analyse the overall residual risk.
Generate links between risk management processes and key quality management processes such as design, change control, CAPA and post-production activities.