| Upcoming Classes | Location | Price | Buy Now |
|---|---|---|---|
| Mar 29 2010 - Mar 30 2010 | Online | 500.00 | |
| Jul 12 2010 - Jul 13 2010 | Online | 500.00 | |
| Sep 13 2010 - Sep 14 2010 | Online | 500.00 | Add to cart |
Group Pricing: Enroll two students at full price and receive a third seat FREE. Please call our office at 888-291-9788 for group registration.
Course Description:
What is computer system validation? Which systems do you need to validate? Where does validation fit into your SDLC or SALC? These are some of the questions answered in this live e-learning course.

This introductory class helps managers and team members establish a solid foundation for understanding the key concepts and skills needed to successfully deliver IT solutions in an FDA regulated environment. This course establishes your knowledge base by focusing on the essential elements of computer system validation --- all without leaving the office.
- Introduction to the key FDA & international regulations and guidance
- An overview of the computer system validation framework and deliverables
- The basics of validation testing: IQ, OQ, PQ documents, such as 21 CFR Part 11, that you need to know
- System owners, IT Managers and Directors new to the FDA regulated environment
- Quality Assurance professionals new to software quality
- Computer system Project Managers and team members who need to understand the validation process
student reference materials, Certificate of Completion

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