CSV - Intermediate

Computer System Validation: Periodic Review Strategies Part 2

This course focuses on providing an understanding of periodic review strategies for validated computer systems, as well as the associated regulations and guidelines affecting these practices. The purpose of this course is to present the regulations and guidance information in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.

CEU Credits: 0.1

Course Code: ELM-149B

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Program Introduction

Course Overview

Learning Objectives

Definitions

Module 4: Review of a System

Module Overview

Review Preparation

Conducting the Review

Periodic Review Sample Checklist

Overview of the CSV Periodic Review Process

Periodic Review vs. Continual Monitoring

GAMP® 5 Guidance on Conducting the Review

Output from the Review

Module 5: Consequences of Periodic Review Failures

Module Overview

Business Consequences

FDA Form 483 and Warning Letters

Form 483

Warning Letters

Lessons from FDA Warning Letters and Citations

Cambrex Profarmaco Milano FDA Warning Letter

Hospira FDA Form 483

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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