Developing and Using the Product Risk Management File & Report
May 26, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
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". Areas Covered in the Session: The Revised ISO 14971:2007 for Devices ICH Q9 for Pharma Product Hazard Analysis Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis Fault Tree Analysis Suggested Risk Management File / Report, FMECA, FTA Templates The Team and Its Involvement - Who, When and How Using the Completed Document - It's Real Value "In the Loop" Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1CGKGfO support@compliance4all.com www.compliance4all.com