QRM

ELM-232a 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: 29/08/2022

Curriculum for this course

Content Warning
08 secs
Course Overview
40 secs
What You’ll Learn
53 secs
Quality Risk Management Definition
1 min 07 secs
What is ICH Q9?
30 secs
QRM Principles
26 secs
The Benefits of QRM
1 min 10 secs
QRM in Action
1 min 05 secs
Quality Risk Management (QRM) Quick Knowledge Check
1 min
General QRM Process
30 secs
QRM Process Initiation
29 secs
Risk Assessment
59 secs
Risk Control
1 min 05 secs
Output of the QRM Process
1 min 30 secs
Risk Review
1 min 03 secs
Risk Communication
1 min 20 secs
Basic Risk Management Facilitation Methods
1 min
Advanced Risk Management Facilitation Methods
1 min 20 secs
Quality Risk Management Process Quick Knowledge Check
1 min
Why is QRM Important?
1 min 01 secs
Situation
51 secs
Action
1 min 09 secs
Outcome
1 min15 secs
Why QRM is Important Quick Knowledge Check
1 min
Conclusion
38 secs
What We Covered
51 secs
Test Your Knowledge
2 mins
Certification
10 secs
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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