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