Improved Quality Management System Benefits
- New Market Penetration and Top Line Revenue Growth
- Product Differentiation and the Competitive Edge
- High Value Innovative Products
- Improved Quality with FDA and ISO Compliance
- Faster Time to Market
- Increased Sales
- Improved Product Quality
- Process Improvement
- Process Efficiencies and Cost Reduction
Winovia can get you there.
Win with the unique combination of technology, manufacturing, quality and marketing expertise Winovia can offer you.
About Vinny Sastri, PhD
President and Founder of Winovia LLCContact Dr Sastri
(+01) 773 348-8577
Vinny Sastri, Ph.D., is the President of WINOVIA® LLC which 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, CAPA and plastics. He is a certified Six Sigma black-belt. He has a strong track record in instituting and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence.
Dr. Sastri is the author of the book Plastics in Medical Devices: Properties, Requirements and Applications the 2nd Edition of which published by Elsevier, London in 2013.
Read Full Biography
Dr. Sastri is 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 and Risk Management to the medical device industry.
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.
Consulting and training specialties:
- Quality systems and good manufacturing practices (FDA 21 CFR Parts 210, 211, 820) ISO 13485; ICH Q7 and Q10
- Product life cycle management; new product development processes; Design for Six Sigma
- Corrective action and preventive action (CAPA) and complaint handling
- Manufacturing and process validation
- Quality risk management (ISO 14971, ICH Q9, HACCP, FTA, FMEA)
- Supplier controls
- Change management
- Project management
- Strategic technology road-mapping
- Plastics in medical devices
- 8 Warning Letter remediations
- 4 Consent Decree remediations
- Worked with top management and stake holders in 6 projects to provide subject matter expertise and advise in Quality Management Systems and remediation strategies
- Risk Management from one consent decree remediation and two warning letter remediations had no observations on FDA recertification. The risk management systems were highlighted as best-in-class including its integration into design controls
Formulated master validation plans for two warning letters. Execution and completion of the master validation plans lifted/closed warning letters with no observations
- Implementation of new / revised quality management systems resulted in zero observations after FDA inspections for two companies, and zero observations by notified bodies for one company
- Hands-on experience in developing procedures, processes and training for remediation activities in design controls, risk management, production and process controls, process validation and CAPA
- Keynote speaker at the Risk acceptability and Life Cycle Risk Management Conference held February 23rd and 24th 2016 in Washington DC with large FDA participation