| Upcoming Classes | Location | Price | Buy Now |
|---|---|---|---|
| Dec 5 2011 - Dec 6 2011 | Online | 500.00 | Add to cart |
| Mar 12 2012 - Mar 13 2012 | Online | 500.00 | Add to cart |
| Jun 18 2012 - Jun 19 2012 | Online | 500.00 | Add to cart |
| Sep 17 2012 - Sep 18 2012 | Online | 500.00 | Add to cart |
| Dec 10 2012 - Dec 11 2012 | 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 317-275-2870 for group registration.
Private Session: $2,500 for the first five students. Each additional student is $250. Please call our office at 317-275-2870 to schedule your private session.
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