How does Risk Management Impact Supply Management

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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How does Risk Management Impact Supply Management

How does Risk Management Impact Supply Management

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Instructor : Edwin L Bills

Product Id : 600022

Overview:

Supply Management is becoming a focus of medical device regulators due to recalls involving components of devices. One of the ways for a manufacturer to focus limited resources in supply management is trough the use of risk management to determine where product safety is impacted by suppliers.

Areas Covered in the Session:

Regulatory requirements on suppliers
GHTF Supplier Guidance
Supplier Selection and Risk Management
Identifying High Risk supplier products
Risk Analysis and Essential Design Outputs
Risk Communication to Suppliers
Supplier Activities for Essential Design Outputs

Who Will Benefit:

Purchasing Mangement
Quality Management
Regulatory Affairs Managers
Supplier Quality Engineers
Product Design Engineers
Internal Quality Auditors

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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