EU MDR - Introductions and Overview - Risk Management and the EU MDR
Apr 06, 2020 11:05 AM - 11:50 AM
Risk Acceptability Criteria
Apr 06, 2020 2:15 PM - 3:30 PM
Common Misconceptions & Wrap up for the day
Apr 06, 2020 3:30 PM - 4:00 PM
Practical Application of Risk Management for EU MDR
Apr 07, 2020 2:00 PM - 2:45 PM
Tying it all together - EU MDR/Risk Management/Post Market Surveillance
Apr 07, 2020 2:45 PM - 3:30 PM
Q&A & Wrap-up
Apr 07, 2020 3:30 PM - 4:00 PM
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.