QRM

The Fundamentals of Quality Risk Management (QRM)

Quality Risk Management (or Q.R.M.) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulatory agencies expect that QRM is inherently built into the backbone of the Quality Management System (or Q.M.S.). This course will give you a surface-level understanding of Quality Risk Management (QRM) in the pharmaceutical industry. This includes the approach and practices, and most commonly used tools and techniques to improve your decision-making skills, and better protect your company and patients by addressing both proactive and reactive risk management.

CEU Credits: 0.1
Course Code: ELM-232a
Duration: 20 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.7
Effective Date: 08/29/2022

Curriculum for this course

Content Warning
Course Overview
What You’ll Learn
Quality Risk Management Definition
What is ICH Q9?
QRM Principles
The Benefits of QRM
QRM in Action
Quality Risk Management (QRM) Quick Knowledge Check
General QRM Process
QRM Process Initiation
Risk Assessment
Risk Control
Output of the QRM Process
Risk Review
Risk Communication
Basic Risk Management Facilitation Methods
Advanced Risk Management Facilitation Methods
Quality Risk Management Process Quick Knowledge Check
Why is QRM Important?
Situation
Action
Outcome
Why QRM is Important Quick Knowledge Check
Conclusion
What We Covered
Test Your Knowledge
Certification
Minor update: Course updated to reflect changes in ICH Q9 (R1) and update to new navigation standards
V1.7
Updated course title
V1.6
Updated course to improve quiz question content and clarity
V1.5
Updated course title
V1.4

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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