Overview: This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 and Q9 models to perform and document such activities for any medical product. It will examine the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and training tool, and how to maintain it as a "living document". Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk management documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities, as well as CAPA resolution actions, in the company.High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to "toughen" its approach to product clearance and approval, while reducing liability issues.Why should you attend: The U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the 'state of the art' at the time. ISO 14971 and ICH Q9 provide accepted methodologies by which to perform and document such an analysis and is accepted by the FDA. The degree of risk can be a determinant on the level of failure investigation, validation effort, et al, required of those activities. The resulting documentation can also be used as a method to train new hires, especially in Marketing, QA/RA, Engineering, and Manufacturing. Areas Covered in the Session:The Revised ISO 14971:2007/9 for DevicesICH Q9 for PharmaProduct Hazard AnalysisDesign, Process, and Use[r] Failure Mode, Effects and Criticality AnalysisFault Tree AnalysisSuggested Risk Management File / Report, FMECA, FTA TemplatesWhy and How to use the ISO 14971 "Model" in all Regulated IndustriesThe Team and It’s Involvement - Who, When and HowUsing the Completed Document - It's Real Value "In the Loop"GlobalCompliancePanelPrice: $225.00Phone: 800-447-9407Fax: 302-288-6884