Risk Analysis and Human Factors Engineering - ComplianceOnline (The Risk analysis tr)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

This presentation explains how to develop an integrated program incorporating risk analysis and human factors engineering. We review the current FDA regulations, ISO 14971:2007 on Risk Analysis, the FDA guidance on Human Factors Engineering, and the FDA guidance on Incorporating Human Factors Engineering into Risk Management. From these documents we derive the fundamentals elements for an effective program and show they can be combined. The presentation incorporates these techniques into the overall product lifecycle using the principles of ISO 14971.

Venue

Additional Information

This presentation explains how to develop an integrated program incorporating risk analysis and human factors engineering. We review the current FDA regulations, ISO 14971:2007 on Risk Analysis, the FDA guidance on Human Factors Engineering, and the FDA guidance on Incorporating Human Factors Engineering into Risk Management. From these documents we derive the fundamentals elements for an effective program and show they can be combined. The presentation incorporates these techniques into the overall product lifecycle using the principles of ISO 14971.