CSV - Intermediate

Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5

Upon completion of this course you will be able to, understand the importance of computer system validation, the regulations and standards behind CSV, recommendations and best practices for CSV, understand the role of GAMP®5 and the competence required for a validation team.

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CEU Credits: 0.1
Course Code: ELM-132
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.1
Effective Date: 08/24/2023

Curriculum for this course

Overview
Learning objectives
Who should I take this course?
Course modules
Where is software used?
Validation is more than testing
Scope of this course
Why validate – Part 1
Why validate – Part 2
Hope through validation
Regulations, standards and guidance
Recommendations and best practices - GAMP®5
Governance
Validation: Basic concepts
GAMP®5 categories
GAMP®5 roles and responsibilities
Process owner
System owner
Subject matter experts
Quality unit
Supplier
End user
Validation team competence

Conclusion

Final Assessment

Certification

Course updated to resolve quiz functionality issue.
V2.1
Redesigned course with new Articulate Storyline player
V2.0

Author

Kevin Martin

Managing Partner at Azzur

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