EU MDR Risk Management Virtual Workshop

 



Speakers

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Edwin Bills
Accomplished professional with extensive experience in US and international healthcare regulatory affairs, product risk management, new product design/development regulation, servicing, standards development, and product liability management. Leadership experience with both internal and external (domestic and international) project teams. Creative in accomplishing organizational goals, within a context of comprehensive customer/market knowledge and deep personal integrity. Solid developer of others, capable trainer and interactive public speaker. International team experience in development of standards and processes. Solid computer skills.
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Mark Leimbeck

Mark Leimbeck is a Program Manager for UL Health Sciences with over 35 years of experience in product safety, including Subject Matter Expert and Advisory engagements in functional areas including Risk Management; Quality Management; Project Management; Software Application Development; and Engineering. He has authored numerous papers, presentations and training programs given in a variety of forums and formats. Mark continues in a Subject Matter and Advisory role, and participates in international, national and industry based standards and guidance development committees. He holds a B.S. E.E.T. from Southern Illinois University and an M.B.A from the University of Chicago.

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Vinny Sastri, Ph.D.
Vinny Sastri, Ph.D., is the president of Winovia LLC, a company that provides consulting, training, quality system assessments and auditing services to medical device pharmaceutical and materials manufacturers. Dr. Sastri is a leading expert in FDA and ISO quality management systems, product development, design controls, risk management, manufacturing and process validation, six sigma and design for six sigma, CA/PA and materials. He is a certified Six Sigma black-belt. He has a strong track record in leading, managing, establishing, establishing and implementing quality initiatives into client organizations around the world, resulting in efficient and effective quality management systems and operational excellence.
Sastri obtained his Ph.D. in chemistry from Rutgers University in New Brunswick, NJ.
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