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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