Risk Based Equipment Qualification
Description:
The primary goal of this eLearning course is to introduce and enhance the learner’s expertise in equipment validation and qualification. We begin by exploring the nuanced differences between validation and qualification, their respective principles, and their practical implications on safety and business operations. Learners will then learn to align regulatory requirements with equipment validation and process qualification, and gain proficiency in impact-based qualification and need assessment methodologies. The course concludes by covering the essential phases of equipment qualification along with the associated documentation.
Curriculum for this course:
Welcome
| Course Introduction | 45 secs |
| What You Will Learn | 26 secs |
Visualizing Equipment Qualification
| Finish Fill Line | 1 min 24 secs |
| The Benefits of Risk-Based Equipment Qualification | 26 secs |
Equipment Qualification Planning
| Equipment Qualification Process | 33 secs |
| Qualification Planning | 18 secs |
| Risk Based Impact and Classification | 42 secs |
| Direct Impact | 1 min 7 secs |
| Indirect Impact | 49 secs |
| No Impact | 19 secs |
Qualification Phases
| Acceptance Testing | 19 secs |
| Factory Acceptance Testing | 44 secs |
| Site Acceptance Testing (SAT) | 48 secs |
| Equipment Design Qualification and Documents | 44 secs |
| Equipment Installation Qualification | 57 secs |
| Equipment Operational Qualification | 48 secs |
| OQ, Commissioning, Pre-Conditions for Execution | 1 min 17 secs |
| Equipment Performance Qualification and Pre-Conditions for Execution | 1 min 29 secs |
GMP Procedures and Programs
| Recertification | 1 min 12 secs |
| Change Control | 55 secs |
| Lets Practice! | 30 secs |
Conclusion
| Conclusion | 43 secs |
| What We Covered | 21 secs |
Test Your Knowledge
Results
Revision History
| Major: This course has been redesigned. The course content, objectives, and visual design have been streamlined and updated to comply with the latest learning theory advances and risk-based qualification methods. | V2.0 |
| Course updated to resolve quiz functionality issue | V1.1 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-121 -
Duration: 16 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V2.0 -
Effective Date: 31/10/2023
Reviews:
It was a no-brainer for us to incorporate this module into our LMS
We use this course to train our engineers who have little experience in this area.
Course layout and content is superb
As someone who is new, to risk based qualifications this course explained a lot for me.
Well-structured and quality content, extremely positive feedback from our validation team.
Related courses:
How to Write an Effective Equipment User Requirement Specification (URS)
cGMP – Equipment, Validation, Complaints and Self Inspection
Contamination Prevention and Control in a GMP Environment
21 CFR Part 820 Subpart G – Production and Process Controls
The Life Cycle of a Software Validation Protocol
How to Write Effective Standard Operating Procedures (SOPs)
Contamination Control Strategies in a GMP Environment
How To Be An Effective GMP Auditor – Part 3
An Introduction to Cleaning Validation
Process Validation: Core Concepts
An Introduction to Process Validation – Part 2
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