Introduction to Computer System Validation--CS 101
"I've done validation before, what's different about validating computer systems?"
This elementary level seminar is a great introduction to the principles and concepts FDA expects when it comes to Computer System Validation. This live e-learning course is great if you are new to computer systems, new to FDA regulations, or both.
Topics:
- Overview of the FDA guidance documents for medical devices, pharmaceuticals, and clinical research software
- Understanding the overall computer system validation framework and deliverables
- The importance of developing good requirement and specification documents
- Test plans, test scripts and test execution
- Overview of 21 CFR Part 11 applicability and requirements
Prerequisites: None
Text/Materials: Course Manual
Contact Hours/PDUs: 6
Duration and Price: 2 afternoons, $500
There are no dates currently scheduled. Please contact us at 317-275-2870 if you are interested in this course.