Computer System Validation: Periodic Review Strategies Part 2

Description:

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:
Program Introduction
Course Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Definitions 1 min 21 secs
Module 4: Review of a System
Module Overview 1 min 05 sec
Review Preparation 1 min 10 secs
Conducting the Review 1 min 05 secs
Periodic Review Sample Checklist 1 min 15 secs
Overview of the CSV Periodic Review Process 1 min 07 secs
Periodic Review vs. Continual Monitoring 1 min 24 secs
GAMP® 5 Guidance on Conducting the Review 1 min 58 secs
Output from the Review 1 min 13 secs
Module 5: Consequences of Periodic Review Failures
Module Overview 1 min 12 secs
Business Consequences 1 mins 29 secs
FDA Form 483 and Warning Letters 1 min 21 secs
Form 483 1 min 25 secs
Warning Letters 1 min 10 secs
Lessons from FDA Warning Letters and Citations 1 min 09 secs
Cambrex Profarmaco Milano FDA Warning Letter 1 min 30 secs
Hospira FDA Form 483 1 min 11 secs
Conclusion
Final Assessment
Certification
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