| Upcoming Classes | Location | Price | Buy Now |
|---|---|---|---|
| Apr 23 2012 - Apr 27 2012 | Chicago | 2995.00 | Add to cart |
| Jul 30 2012 - Aug 3 2012 | Chicago | 2995.00 | Add to cart |
| Oct 15 2012 - Oct 19 2012 | Chicago | 2995.00 | 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: Starting at $13,500 for up to twelve (12) students - that's up to 62% off full price. For larger groups, please contact us for pricing. Call our office at 317-275-2870 to schedule your private session.
Course Description:
Boot camp is tough and challenging. Imagine a week of complete immersion in the validation process - participants will work in focused teams to complete hands-on validation activities through instruction, drills, and case scenarios.
The drills move quickly and participants will change gears often to keep interest high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, hands-on activities, and competitions keeps energy levels high and challenges the participants.
BONUS: Course registration includes a free 90-day standard subscription to Validation Center™.
Praxis' Computer System Validation Experience:
We've been there; we've done it. We've planned, managed, and executed risk-based validation projects for pharmaceutical and medical device companies - we know what works, what doesn't, and where mistakes are commonly made. We've designed the standard operating procedures, guidelines, and templates that companies have successfully used to pass FDA audits. We're focused on results, learning and applying real skills that will result in a more efficient and effective validation work product.
- The overall computer system validation framework and the purpose and content of each deliverable
- Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC)
- Hands-on practice creating key validation deliverables, including Requirements, Test Plan, Validation Tests (IQ, OQ, PQ), and Test Summary
- Best practices for validation test execution, documentation, and error handling
- Comprehension of what software requires validation
- Concepts and implementation model for a risk-based approach to CSV
- Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations. Includes details on how to leverage risk-based decision making in the procedures used from system conception to syste retirement.
- Understanding of the key FDA and international regulations and guidance regarding CSV and which apply to your company
- Current data and 9 years of trends on the most common FDA warnings regarding software validation and system quality
IT, QA, & Business Managers and Professionals who need to:
- Manage or participate on computer system projects requiring validation
- Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
- Understand the process of computer system validation
- Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
- Understand the FDA and international regulatory landscape around CSV
Pre-Work Packet, course binder, 90-day standard subscription to Validation Center™, continental breakfast, lunch and afternoon snack.
This course requires you to bring a laptop to class. You will need internet access, a spreadsheet & word processing application and a PDF reader. You will NOT be required to install any software.