CSV - Intermediate

Computer System Validation: Periodic Review Strategies Part 1

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.

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CEU Credits: 0.1
Course Code: ELM-149A
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Course Introduction
Who Should Take This Course?
Learning Objectives
Definitions
Module Overview
What is a Periodic Review?
Why Periodic Reviews Are Necessary
Objectives of Periodic Review
Benefits of Periodic Review
Module Overview
FDA (US)
21 CFR Part 211 Subpart D – Equipment
FDA Compliance Policy Guide
European Commission (EU)
Annex 11: Computerised Systems
Annex 15: Qualification and Validation
World Health Organization (WHO)
ISPE GAMP®5
Module Overview
Factors in Determining Frequency of Reviews
Events that Trigger Periodic Review
Periodic Review and Gap Analysis
General Approach
Responsibilities
Timing and Scheduling

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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