Quality Risk Management QRM (eLearning)

Understand the regulatory drivers for QRM, with particular emphasis on European and US requirements and expectations 

Understand how ICH Q9 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation 

Understand the principles of QRM, the ICH Q9 framework and the importance of common language and approaches, and the differences between QRM and risk analysis 

Understand how to set up and run a risk management exercise, including team selection, risk assessment, analysis, control, review and communication 

Recognise the importance of product Critical Quality Attributes, Critical Process Parameters and Control Strategy in regard to science and risk-based principles 

Appreciate how to use FMEA, risk ranking, cause effect matrix and other related Risk Analysis techniques, such as process flow diagrams, ‘fishbone’, ‘brainstorming’ etc. 

Have knowledge of the background and detail of the ICH Q9(R1)