Скачать или смотреть ICH Q9 Quality Risk Management Explained # Risk management

Understand the essential principles of ICH Q9 Quality Risk Management (QRM)—the globally recognized framework established by the European Medicines Agency (EMA) to guide risk-based decision-making throughout the pharmaceutical product lifecycle.

This video breaks down the full structure of ICH Q9, highlighting how QRM integrates into drug development, manufacturing, distribution, and regulatory compliance. You’ll learn how multidisciplinary teams apply systematic processes to identify, assess, control, communicate, and continually review risks to ensure patient safety and product quality.

🔍 Key Topics Covered:

✔ What is ICH Q9 and why it matters in pharmaceutical quality systems
✔ How QRM supports lifecycle-based decision-making
✔ Step-by-step risk assessment, risk control & risk review
✔ Overview of QRM tools: FMEA, HAZOP, HACCP, Fault Tree Analysis, Risk Ranking & Filtering
✔ How QRM aligns with GMP, regulatory expectations & continuous improvement
✔ Practical examples from ICH Q9 annexes for real-world implementation

This is a must-watch for professionals in pharmaceutical QA/QC, regulatory affairs, manufacturing, validation, and compliance looking to strengthen their understanding of risk-based approaches.


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