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Live Corporate Webinar : Friday : 2nd November, 2012
02:00 PM EDT | 11:00 AM PDT

ISO 14971, Risk Management for Medical Devices
Presented by - Dan O'Leary, President, Ombu Enterprises, LLC
Duration of webinar : 60 Mins | Duration of Q/A session : 10-15 mins
Deliverables : Copy of presentation slides will be shared
Short Abstract:
This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. The webinar describes the flow of information in the Risk Management system looking at important terms including Hazard, Harm, and Risk and explaining how to use each one. The program describes a Risk Evaluation method that implements the requirements of ISO 14971:2007. The program covers the issues of risk reduction and explains the priority order.

This presentation will cover the following areas :

  • Risk Management Plan.
  • Risk Analysis.
  • Risk Control.
  • Overall Residual Risk.
  • The Risk Management Report.
  • Production Information collection.
  • Post-production Information Collection.
Who Should Attend :
Medical Device companies/professionals including
  • Risk Management
  • Regulatory Affairs (Associates, Specialists, and Managers)
  • Quality Professionals (Associates, Specialists, Auditors, Engineers, and Managers)
  • Research and Development (R&D) (Engineers and Managers)
  • Complaint Handling and Risk Management Professionals
  • Technical Documentation
Upcoming Webinars
FDA’s General Controls for Medical Device Manufacturers
- 9th Nov,2012 | 02:00PM EST | 11:00AM PST
Optimal clinical supply planning for global drug development
- 16th Nov,2012 | 02:00PM EST | 11:00AM PST

Unbable to attend Live Presentation:

Register for RECORDED Webinar (Registration Fees : USD $399)

Speaker Profile:
Dan O’Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics. His professional experience relates to quality, reliability, project management, and operations management. Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management. more...
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