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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.

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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