Learn to apply ICH Q9(R1) Quality Risk Management in everyday GMP work. Understand why QRM matters and what regulators expect, the principles and the QRM process, how to assess and control risk, and how to link QRM with CAPA and the pharmaceutical quality system. Practise basic tools, risk ranking, HAZOP, FMEA, FTA and HACCP, and see how QRM drives daily decisions.

A practical, end-to-end toolkit for solving quality problems in regulated environments. Build a quality culture, turn problems into focused projects, generate and prioritise ideas, listen to patients and customers, map the real process, check that your data can be trusted, and make it speak with Pareto charts, trends, control charts and capability studies. Then dig to the root cause, test what really drives results, prevent problems with FMEA, and hold the gains with control plans.