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Fall 2011 Seminars
Past seminars
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Risk Management/ISO 14971
This course provides participants with the knowledge, tools and confidence to develop
a risk management program. As a management tool used throughout a product’s life,
risk analysis can reduce errors, liability and cost by prioritizing the most important
risk concerns early. The course will feature both lecture and an active question-and-answer
portion to bring real life situations to participants.
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What you will learn:
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Course Topics:
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Understand the principles of risk management planning in developing procedures and
practices to analyze, evaluate and mitigate risks.
Understand what the FDA and EU will expect from your company in applying risk analysis
to medical devices.
Understand the application of risk analysis methodologies such as FMEA and FTA.
How to develop a risk reduction plan.
Practical knowledge to not only discover but also organize, document, and mitigate
risks.
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Understanding Risk
ISO 14971 Overview
Infant Heel Warmer example
Definitions and Concepts
Risk Management Planning
Risk Assessment
Risk Control
Residual Risk Evaluation
Risk Management Report
Production & Post-production Information
Project Risk Management
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Instructor, 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, focusing on logic
and number theory. His professional experience relates to quality, reliability and
operations management. Dan is the President of Ombu Enterprises, LLC, a company
offering training and execution in Operational Excellence. Ombu helps companies
achieve efficient and effective processes and regulatory compliance.
Dan is a regular speaker at international conferences including ASQ, ISM and RAMS.
Dan teaches courses in reliability methods, medical device regulations and practices,
statistical methods, management systems (ISO 9001 & ISO 14001) and project management.
Dan is a member of the American Mathematical Society, American Statistical Association,
Society of Industrial and Applied Mathematicians, Institute for Supply Management,
Project management institute, APICS and is a Senior Member of the American Society
for Quality and has held leadership positions in ASQ sections. He is an ASQ Certified
Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and
Six Sigma Black Belt; and certified by APICS in Resource Management.
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WHEN:
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October 21-22, 2010 |
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WHERE:
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Best Western Royal Plaza,
Marlborough, MA |
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Course Code:
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110 |
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TIME:
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9:00 am to 5:00 pm |
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TO REGISTER PLEASE VISIT OUR WEBSITE.
NEQC Administration, Phone: (508) 987-3800 Fax: (508) 987-1464
E-mail: Registration@neqc.org
Website: www.neqc.org
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