Скачать или смотреть Pharmaceutical QRM Essentials: Risk Assessment, FMEA & RPN Calculations

Master the essentials of Quality Risk Management (QRM) in the pharmaceutical industry. This comprehensive guide covers ICH Q9 principles, risk assessment tools like FMEA, and how to calculate Risk Priority Numbers (RPN) to ensure product safety and compliance.

​[Timestamp/Chapters]
00:00 - Introduction to Quality Risk Management (QRM)
01:15 - The 5 Parameters of Quality: SISPQ Explained [01:15]
04:16 - Product Stability and Identity Risk [04:16]
07:10 - Defining Risk, Hazard, and Management [07:10]
11:23 - QRM Tools: FMEA, HACCP, and FTA [11:23]
15:04 - Risk Identification and Severity [15:04]
21:28 - How to Calculate RPN (Risk Priority Number) [21:28]
24:19 - Creating a Risk Matrix: Minor, Major, and Critical [24:19]
29:26 - Conclusion & Part 2 Preview

In this video, we dive deep into the framework of Quality Risk Management as per global pharmaceutical standards. Understanding QRM is vital for passing FDA (US) and MHRA (UK) audits.

​What you will learn:
​SISPQ: Why Strength, Identity, Stability, Purity, and Quality/Quantity are the pillars of pharma quality.
​Risk Evaluation: How to identify potential hazards before they impact the patient.

​Quantifying Risk: A step-by-step breakdown of using Severity (S), Occurrence (O), and Detectability (D) to find your RPN.

​Decision Making: Using the Risk Matrix to categorize risks and implement corrective actions.

​Who is this for?
QA/QC Professionals, Production Managers, Pharmacy Students, and Compliance Officers looking to strengthen their technical knowledge.
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If you found this technical breakdown helpful, please Like and Subscribe for Part 2! Leave a comment below if you have questions about specific QRM tools like FMEA or HACCP.

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