Medical Device Quality Management Systems that are Efficient, Effective, Sustainable, Usable, and Compliant. Winovia can help you get there.
About Vinny Sastri, PhD
President and Founder of Winovia LLC
Vinny Sastri, Ph.D., is the President of WINOVIA ® LLC. WINOVIA provides customized solutions, strategies and training in the implementation of effective quality management systems. Areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, supplier controls, CA/PA and materials. He is a certified Six Sigma black-belt. He has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence.
Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation, Supplier Controls and Risk Management to the medical device industry. He now conducts public and in-house training in process validation, design controls and risk management through his company Winovia LLC.
Prior to starting WINOVIA, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies like BASF, AlliedSignal and General Electric. Dr. Sastri earned a Ph.D. from Rutgers University, and completed post-doctoral work at Brooklyn Polytechnic Institute.
He was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. He has over 20 publications and 6 patents and has presented at many international conferences and webinars in the United States, Europe and Asia.
Dr. Sastri is the author of the book Plastics in Medical Devices: Properties, Requirements and Applications the 3rd Edition, published by Elsevier, London.
A comprehensive survey including applications, production, unique properties, and techniques to enhance properties with examples of real-world use. Includes chapters on Process Validation and Supplier Controls.Buy on Amazon
Consulting and training specialties include:
- Leading remediation projects; functioning as the acting or interim Director of Quality Systems
- Product life cycle management; new product development processes; Design for Six Sigma, Design Controls
- Manufacturing and operational excellence, Six Sigma and Process Validation
- Supplier Controls / Supplier Quality
- Corrective Action and Preventive Action (CA/PA)
- Strategic Technology Road-mapping
- Quality Management Systems and good manufacturing practices (FDA 21 CFR Parts 210, 211, 820; ISO 13485; ISO 9001; ISO 16949; ICH Q7 and Q10)
- Change Control
- Risk Management (ISO 14971, ICH Q9, HACCP, FTA, FMEA)
- Change Management
- Project Management
- Plastics in Medical Devices
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