GlobalCompliancePanel , Online
March 2, 2010
Companies have been applying the techniques of ISO 14971 to product safety, but the techniques can also be applied to other risks encountered in all companies. The new ISO standard, ISO 31000 is a general risk management standard for businesses and is based on ISO 14971. Businesses have to deal with the risks of regulatory compliance, project success risks, and other risks on a daily basis. The techniques of risk management can successfully be applied to manage the risks aid in decision-making to reduce the impact of these factors on businesses in today's economy. Areas Covered in the Session: - The general principles of risk management
- Types of risk to businesses
- Establishing risk acceptability
- Developing processes to deal with risk
- Establishing risk management responsibilities
- Implementing risk management for business risks
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Invited Speakers:
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Edwin L Bills
Principal Consultant, Bilanx Consulting LLC During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
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