Implementing a Risk-Based Approach to Part 11 Compliance
Agenda: Day One
I. Explain FDA's Current Interpretation of 21 CFR Part 11
II. Identify Applicable Requirements within the Predicate Rules
III. Illustrate Risk Analysis Techniques
IV. Apply Risk Management to Computer and Software Systems
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.