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.

Curriculum for this course:
Course Introduction 1 min 01 secs
Who Should Take This Course? 1 min 31 secs
Learning Objectives 1 min 21 secs
Definitions 1 min 10 secs
Module 1: Introduction to Periodic Review
Module Overview 1 min 05 sec
What is a Periodic Review? 1 min 10 secs
Why Periodic Reviews Are Necessary 1 min 05 secs
Objectives of Periodic Review 1 min 15 secs
Benefits of Periodic Review 1 min 07 secs
Module 2: Regulatory Requirements and Guidelines for Periodic Review
Module Overview 1 min 12 secs
FDA (US) 1 mins 29 secs
21 CFR Part 211 Subpart D – Equipment 1 min 21 secs
FDA Compliance Policy Guide 1 min 25 secs
European Commission (EU) 1 min 10 secs
Annex 11: Computerised Systems 1 min 09 secs
Annex 15: Qualification and Validation 1 min 30 secs
World Health Organization (WHO) 1 min 11 secs
ISPE GAMP®5 1 min 14 secs
Module 3: Considerations for Periodic Review
Module Overview 58 secs
Factors in Determining Frequency of Reviews 1 min 20 secs
Events that Trigger Periodic Review 1 min 01secs
Periodic Review and Gap Analysis 1 min 19 secs
General Approach 1 min 14 secs
Responsibilities 1 min 18 secs
Timing and Scheduling 1 min 22 secs
Final Assessment

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