| Upcoming Classes | Location | Price | Buy Now |
|---|---|---|---|
| May 10 2010 - May 14 2010 | Chicago | 2995.00 | Add to cart |
| Aug 23 2010 - Aug 27 2010 | Chicago | 2995.00 | Add to cart |
| Oct 11 2010 - Oct 15 2010 | Chicago | 2995.00 | Add to cart |
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 internet access, a word processing application and a spreadsheet application. You will NOT be required to install any software. If you do not have a laptop, please let us know and we will arrange a loaner for you.