Computer System Validation Boot Camp®
a little theory . . . and a lot of practice
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 CenterTM.
Praxis' Computer System Validation Experience:
We've been there; we've done it. We've planned, managed, and executed validation projects for a number of 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.
Topics
- The origin and purpose of computer system validation
- The fundamental principles of software quality assurance
- How to apply quality principles throughout the software development life cycle
- Key FDA and European regulations related to computer systems
- How to create the validation deliverables produced during a project including requirements, testing, validation plan, and summary documents.
- Understanding the principles and current application of electronic records / signatures regulation (21 CFR Part 11)
Who Should Attend?
- IT professionals working in a regulated environment
- Validation Team Leads
- Software Quality Assurance professionals
- Management new to IT in a regulated industry
- Anyone who needs hands-on experience to develop successful computer system validation techniques
Prerequisites: NoneText/Materials Included: Pre-Work Packet, course binder, 90-day standard subscription to Validation CenterTM, continental breakfast and lunch each day.
Items You Should Bring: Your completed pre-work packet, casual/comfortable clothes, and a laptop computer (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.) Bringing a laptop computer to the Philadelphia location is optional.
Duration: 5 day workshop
Professional Development Credits: 36 PDUs
Cost: $2,995
Course Dates and Location:
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November 17-21, 2008 |
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| February 23-27, 2009 |
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| April 27-May 1, 2009 |
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| June 22-26, 2009 |
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| August 17-21, 2009 |
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| October 19-23, 2009 |
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| December 14-18, 2009 |
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