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

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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