The Fundamentals of Quality Risk Management (QRM)
Description:
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.
Curriculum for this course:
Course Introduction
| Content Warning | 08 secs |
| Course Overview | 40 secs |
| What You’ll Learn | 53 secs |
What is Quality Risk Management (QRM)?
| 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 |
Quality Risk Management Process
| 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 |
QRM Methodologies and Tools
| 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 |
Real Life Impacts of QRM
| Situation | 51 secs |
| Action | 1 min 09 secs |
| Outcome | 1 min15 secs |
| Why QRM is Important Quick Knowledge Check | 1 min |
Conclusion
| Conclusion | 38 secs |
| What We Covered | 51 secs |
| Test Your Knowledge | 2 mins |
| Certification | 10 secs |
Revision History
| Updated course title | V1.6 |
| Updated course to improve quiz question content and clarity | V1.5 |
| Updated course title | V1.4 |
Author:
Book a demo
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-232a -
Duration: 30 mins -
Skill Level: Basic -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V1.6 -
Effective Date: 29/08/2022
Related courses:
Computer System Validation – Risk Management
Course code: ELM-162
Private: An Introduction to Software Validation – Part 1
Course code: ELM-113
An Introduction to Process Validation – Part 2
Course code: ELM-402
cGMP – Equipment, Validation, Complaints and Self Inspection
Course code: ELM-203
Commissioning Qualification and Validation the Concept of CQV – Part 2
Course code: ELM-182
Commissioning Qualification and Validation the Concept of CQV – Part 3
Course code: ELM-183
Risk Based Equipment Qualification
Course code: ELM-121
Commissioning Qualification and Validation the Concept of CQV – Part 1
Course code: ELM-181
An Introduction to Medical Device Validation – Part 2
Course code: ELM-157
Computer System Validation – The Master Validation Plan (MVP)
Course code: ELM-163
Computer System Validation – Application of the Validation Plan
Course code: ELM-164
Change Control and Change Management
Course code: ELM-160
Computer System Validation – Supplier Provided Software
Course code: ELM-166B
Talk to us
Find out how we can help you bring your life science training to the next level.