ICH Q9-QUALITY RISK MANAGEMEN

#ich #q9 Guideline: Comprehensive Tutorial on #quality #risk #management in #Pharmaceuticals
Welcome to our in-depth tutorial on the ICH Q9 Guideline! This video by #pharmamentors covers everything you need to know about Quality Risk Management (#QRM) as outlined in the ICH Q9 guideline, which plays a critical role in pharmaceutical quality systems. Whether you're a beginner or looking to refresh your knowledge, this tutorial is designed to provide a clear and detailed understanding of the Q9 framework.

What You’ll Learn:
-What is ICH Q9? An overview of the International Council for Harmonisation’s guideline on Quality Risk Management.
Key Concepts: Definitions of risk, risk assessment, control, and communication in the context of pharmaceutical quality.
Risk Management Process: A breakdown of the steps involved in identifying, assessing, controlling, and reviewing risks.
*Application of QRM:* How to practically apply risk management to various processes such as manufacturing, testing, and regulatory compliance.
*Tools for Risk Management:* An introduction to common tools like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and more.

Who is this video for?
This video is ideal for professionals in the pharmaceutical, biotech, or healthcare industries who work in quality control, regulatory affairs, manufacturing, or any related field where Quality Risk Management is essential.

Why is ICH Q9 Important?
The ICH Q9 guideline provides a structured approach to managing risks, which is essential for ensuring product quality and patient safety. Understanding this guideline will help you meet regulatory expectations and improve the overall quality of pharmaceutical products.
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