Computer System Validation: Periodic Review Strategies Part 1
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:
Introduction
| 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 |
Conclusion
Final Assessment
Certification
Author:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-149A -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Another great course to add to our CSV training program.
An often overlooked aspect of CSV is periodic review. This is an essential aspect of the CSV lifecycle and this course does a great job of explaining it’s importance.
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Computer System Validation (CSV): Validation Testing – Part 2
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