Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Description:
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.
Curriculum for this course:
Introduction
Overview | 1 min 10 secs |
Learning objectives | 1 min 31 secs |
Who should I take this course? | 1 min 18 secs |
Course modules | 1 min 15 secs |
Module 1: Background
Where is software used? | 1 min 42 secs |
Validation is more than testing | 2 min 10 secs |
Scope of this course | 1 min 38 secs |
Why validate – Part 1 | 1 min 42 secs |
Why validate – Part 2 | 1 min 50 secs |
Hope through validation | 1 min 33 secs |
Regulations, standards and guidance | 1 min 58 secs |
Module 2: An Introduction to GAMP®5
Recommendations and best practices – GAMP®5 | 1 min 29 secs |
Governance | 1 min 46 secs |
Validation: Basic concepts | 1 min 37 secs |
GAMP®5 categories | 1 min 47 secs |
GAMP®5 roles and responsibilities | 2 min 05 secs |
Process owner | 1 min 18 secs |
System owner | 1 min 41 secs |
Subject matter experts | 1 min 49 secs |
Quality unit | 1 min 29 secs |
Supplier | 1 min 30 secs |
End user | 1 min 36 secs |
Validation team competence | 1 min 49 secs |
Conclusion
Final Assessment
Certification
Revision History
Redesigned course with new Articulate Storyline player | V2.0 |
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