Computer System Validation – The Master Validation Plan (MVP)
Description:
This course is geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV but we’ve tried to provide sufficient information for folks with non-software backgrounds to jump into the CSV fray. Those in management positions with responsibility for validating computer systems should also find great benefit in this course. In this module we will concentrate on the Master Validation Plan (MVP) and explain how this is such an important aspect of the entire CSV lifecycle.
Curriculum for this course:
Introduction
| Overview | 1 min 01 secs |
| Learning Objectives | 1 min 31 secs |
| Who Should Take This Course? | 1 min 21 secs |
| Course Modules | 1 min 10 secs |
Module 1: Background
| Where is Software Used? | 1 min 05 sec |
| Validation is More than Testing | 1 min 10 secs |
| Scope of this Course | 1 min 10 secs |
| Why Validate – Part 1 | 1 min 10 secs |
| Why Validate – Part 2 | 1 min 07 secs |
| Hope Through Validation | 1 min 24 secs |
| Regulations, Standards and Guidance | 1 min 30 secs |
Module 6: Setting the Foundation for a Risk Based Approach – The MVP
| Solid Foundation | 1 min 12 secs |
| Roles, Responsibility and Authority | 1 mins 29 secs |
| Description of the Facility | 1 min 02 secs |
| Implementing the Risk Based Approach | 1 min 25 secs |
| Patient and GxP Impact | 1 mins 11 secs |
| Risk Matrix | 1 min 38 secs |
| Computer System Types | 1 min 30 secs |
| Why is Categorization Important? | 1 min 11 secs |
| Infrastructure | 1 min 14 secs |
| Non-Configured | 1 min 01 secs |
| Configured – IQ | 1 min 22 secs |
| Configured – OQ | 1 min 40 secs |
| Custom | 1 min 09 secs |
| Governance | 1 min 18 secs |
| Configuration Management | 1 min 18 secs |
| Starting and Stopping | 1 min 05 secs |
| Plan for the Unexpected – Test Failure | 1 min 39 secs |
| Plan for the Unexpected – Protocol Issues | 1 min 19 secs |
| Plan for the Unexpected – Expected Results | 1 min 30 secs |
| Approaches | 1 min 09 secs |
| Prospective Validation | 1 min 12 secs |
| Retrospective Validation | 1 min 15 secs |
| Inventory and Classification | 1 min 22 secs |
| Maintaining the Validated State | 1 min 31 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-163 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
One of the most important aspects of the entire CSV life cycle is the Master Validation Plan. This course explains the MVP in all the detail you need to be successful.
Loved the section of the various categories of software and various approaches. This is a must do course for anyone who is involved with CSV projects.
Related courses:
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Computer System Validation – The Regulated Software Life Cycle
Computer System Validation – Requirements: The Basis for Validation
Computer System Validation – Risk Management
Private: An Introduction to Software Validation – Part 1
Private: An Introduction to Software Validation – Part 2
The Life Cycle of a Software Validation Protocol
21 CFR Part 11 – An Introduction
21 CFR Part 11 – Electronic Records
21 CFR Part 11 – Electronic Signatures
21 CFR Part 11 – 2003 Guidance
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