QRM

ELM-232b Quality Risk Management (QRM): Global Regulations and Their Impact

This course will provide a review of the global regulations, standards, and guidelines related to Quality Risk Management in the pharmaceutical industry. This will help you better understand the scope of activities included in the various QRM requirements as well as their applicability and overlap across the globe.

Additionally, we will explore the departments, roles, and activities that  contribute to the success of Quality Risk Management, and are subject to  the requirements set forth by these regulations, standards, and guidelines. 

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CEU Credits: 0.1
Course Code: ELM-232b
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.5
Effective Date: 13/10/2022

Curriculum for this course

Course Overview
40 secs
What You’ll Learn
53 secs
US FDA Regulations
1 min 07 secs
WHO Regulations
30 secs
ISO 31000:2009
26 secs
ISO 14971:2020
1 min 10 secs
ISO/TR 24971:2020
1 min 05 secs
Pharmaceutical Inspection Convention/ Inspection Co-Operation Scheme
1 min
Quick Knowledge Check

Who is Accountable for QRM

Integrated Quality Management
1 min
Regulatory Operations
1 min 20 secs
Product Development
1 min
Facilities, Equipment and Utilities
1 min 01 secs
Production
58 secs
Lab Control and Stability
45 secs
Packaging and Labeling
1 min 6 secs
Quick Knowledge Check
Conclusion
38 secs
What We Covered
51 secs
Test Your Knowledge
2 mins
Results
10 secs
Minor update: Course updated to reflect changes in ICH Q9 (R1). Two resources were updated and some on-screen text and narration.
V1.5
Updated course title
V1.4
Updated quiz to improve question clarity and content
V1.3
Updated course title
V1.2

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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