About Course
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.
Course Content
Module 1: Why Quality Risk Management
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Why Quality Risk Management
09:05
Module 2: The Regulatory Landscape
Module 3: Principles and the QRM Process
Module 4: Assessing and Controlling Risk
Module 5: Risk-Based CAPA and Integration
Module 6: Basic Tools, Ranking and HAZOP
Module 7: FMEA, FTA and HACCP
Module 8: QRM in Daily Operations
Final Assessment
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