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World's Largest Event for Medical Manufacturing MD&M East Jacob K. June 3-5 2008 Javits Convention Center New York, NY

Conference

Monday, June 2, 2008
9:00 A.M. - 4 P.M.

Session 101 - Risk Management for Medical Devices - Applying ISO 14971 Effectively Using
Risk Assessment and Reliability Tools

Instructors: Andrew Snow, Vice President and General Manager, HEI; and Michael Barile, Managing Partner,
Barile & Associates

Risk management concepts and terminology
Understanding of the regulatory requirements for Risk Management
An introduction to the requirements of ISO 14971:2007
Fundamental concepts of product liability as it relates to risk
Tips for integrating Risk Management into the design and development lifecycle
Basics of how to conduct a compressive risk assessment for a device
Methods for evaluating over-all device risk acceptability
Guidelines for applying FMEA, Fault Tree Analysis and other risk assessment tools to
Risk Management
Understanding of how human factors engineering relates to Risk Management
Familiarity with how reliability engineering tools (e.g. MIL-HDBK-217) can aid the risk
management process
Exposure to advanced methodologies such as Markov Analysis for predicting and simulating
hazardous events

ABOUT THE INSTRUCTORS

Andrew Snow, Vice President and General Manager, HEI

Andrew Snow is a Quality Assurance professional with over 25 years of progressive quality engineering and management experience. He holds a BS in Biology from Fort Lewis College, a Masters in Engineering from Northwestern, and a graduate certificate in Systems Engineering from University of Arizona. He currently is the Vice President and General Manager of Quality and Regulatory for HEI Inc. Prior to this he was a consultant helping numerous companies including Alcon Laboratories and Abbott Laboratories. He has extensive hands on quality assurance, design and manufacturing experience in Medical Devices. He has expertise and proven results in Quality Systems implementation, Process Validation, Design Control, Concurrent Engineering methods and Risk Analysis. Andy is an ASQ certified Quality Engineer, and a trained ISO 9000 Lead Assessor. He was an instructor in Statistics, and Quality and Productivity Management at the University of Phoenix. He has published articles on Risk Management, Design Control and Process Validation.

Michael Barile, Managing Partner, Barile & Associates

Michael Patrick Barile has over twenty five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in turnaround situations. He is the founder and Managing Partner of the consulting firm Barile & Associates. Comprised of a group of senior quality, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the medical device, pharmaceutical, human tissue and biotechnology industries. This support includes complete quality system development; software, process and design validation services; complete design control services; risk management services; 483, Warning Letter and Consent Decree resolution; auditing; crises management; corrective action plan generation and execution; regulatory submissions; training, staffing, and organizational development.

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