Equipment Qualification

Risk Based Equipment Qualification

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.

CEU Credits: 0.1
Course Code: ELM-121
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.1
Effective Date: 10/31/2023

Curriculum for this course

Course Introduction
What You Will Learn
Finish Fill Line
The Benefits of Risk-Based Equipment Qualification
Equipment Qualification Process
Qualification Planning
Risk Based Impact and Classification
Direct Impact
Indirect Impact
No Impact
Acceptance Testing
Factory Acceptance Testing
Site Acceptance Testing (SAT)
Equipment Design Qualification and Documents
Equipment Installation Qualification
Equipment Operational Qualification
OQ, Commissioning, Pre-Conditions for Execution
Equipment Performance Qualification and Pre-Conditions for Execution
Recertification
Change Control
Lets Practice!
Conclusion
What We Covered

Test Your Knowledge

Results

v2.1 - Minor update on 8/9/2024 to remove outdated works cited references and fix quiz functionality
v1.1 - Minor update on 8/29/23 to resolve quiz functionality
v1.0 - Course Released on 01/08/2021

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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