Quality Risk Management (QRM): Global Regulations and Their Impact
Description:
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.
Curriculum for this course:
Course Introduction
| Course Overview | 40 secs |
| What You’ll Learn | 53 secs |
Global QRM Regulations, Standards and Guidelines
| 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
How Quality Risk Management Applies to You
| 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
| Conclusion | 38 secs |
| What We Covered | 51 secs |
| Test Your Knowledge | 2 mins |
| Results | 10 secs |
Revision History
| Updated course title | V1.4 |
| Updated quiz to improve question clarity and content | V1.3 |
| Updated course title | V1.2 |
Author:
Book a demo
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-232b -
Duration: 30 mins -
Skill Level: Basic -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V1.4 -
Effective Date: 13/10/2022
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.