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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