Computer System Validation – Application of the Validation Plan
Description:
Regulations set forth by the FDA establish an expectation that all aspects of a regulated manufacturing process are well-established, documented, and controlled to ensure consistent high-quality products. The Validation Master Plan (VMP) is critical in achieving this goal by documenting compliance requirements and explaining necessary validation activities across a manufacturing operation. Unlike a written plan for a specific validation project, the VMP functions at the top layer control, establishing a defined approach to all validation activities and describing the risk-based strategy for achieving and maintaining a fully-qualified facility supported by all necessity validated processes. The MVP provides an umbrella approach, but the individual plans provide detail specific to the application.
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 7: Application of the Validation Plan
Human Resources | 1 min 12 secs |
Test Equipment | 1 mins 29 secs |
The Software Under Test | 1 min 02 secs |
How Many? | 1 min 25 secs |
Statistically Based Approaches | 1 min 45 secs |
Conclusion
Final Assessment
Certification
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