This 1-day seminar reviews the FDA regulations and industry guidance on risk assessment including GAMP, NIST, and ISO. The seminar addresses the process to complete Risk Assessment and Risk Mitigation activities as applied to computer system validation.
Participants learn how to:
Identify risks as part of the validation planning process
Develop mitigation strategies
Evaluate residual risk
Prepare a Risk Assessment Report and address on-going risk management
The Registration Fee includes attendance, continental breakfast, lunch, and breaks, and an attendee binder containing slides, handouts, and activities.