The US FDA is increasingly stating that many regulated activities should be "risk-based".
Proper "up-front" time spent in developing a realistic "real world" product Risk Management File and Report, can save the product development team time and wasted effort, minimize post-production surprises and recall / liability issues. Attendees will be helped to see how to develop a compliant Hazard Analysis / Risk Management File and Report, as outlined in the newly revised ISO 14971:2007, a standard recognized by the FDA and rapidly being adopted by industry. This will be accomplished by a Case Study of the step-by-step development of a product Risk Management File / Report. Then attendees will see how to use this document to realize practical results for their company and products.