If you are looking for …
- New Market Penetration and Top Line Revenue Growth
- Product Differentiation and the Competitive Edge
- High Value Innovative Products
- Faster Time to Market
- Increased Sales
- Improved Product Quality
- Process Improvement
- Process Efficiencies and Cost Reduction
… then Winovia is the clear choice for you.
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 LLC
Contact Dr Sastri
(+01) 518 436-8110
Vinny Sastri, Ph.D., provides companies customized solutions, strategies, training and implementation of effective, self-sustaining new product development and quality management processes. Areas of expertise include product life cycle management and Design for Six Sigma, manufacturing, process validation and Six Sigma, FDA and ISO quality systems for medical devices and pharmaceuticals, risk management and plastics expertise. He is a certified Six Sigma black-belt and has a strong track record in instituting and implementing growth and quality initiatives into client organizations around the world, resulting in new product sales, manufacturing efficiencies and productivity. His 25 years of experience span technology, manufacturing, marketing and quality in markets like medical devices, plastics, chemicals, pharmaceuticals, automotive, consumer goods, packaging, fibers and textiles.
Dr Sastri is the author of the book Plastics in Medical Devices: Properties, Requirements and Applications published by Elsevier, London in April 2010.
Read Full Biography
Prior to starting WINOVIA, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies like BASF, AlliedSignal and GE Plastics. 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 include:
- 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
Presentations & Webinars
Risk-Based Corrective Action and Preventive Action (CAPA) — New Guidelines and Expectations FXConferences Audio Seminar December 14, 2010
Advanced Process Validation MD&M West February 10 2011, Anaheim, CA; MD&M Florida, March 17, 2011; MD&M East 2010, New York City June 11, 2010 — Full Day Session
Practical Process Validation: Solutions and Strategies for the Medical Device Industry, MD&M West 2010 & 2009, Anaheim California February 9, 2011, February 11, 2010 & February 10 2009, MDM East 2010 & 2009 June 9, 2010 & June 11, 2009, MDM Minneapolis October 21, 2009 — Full Day Session
To validate or not to validate? That is the question for plastics processors in the medical device industry. SPE European Conference on Medical Polymers, Belfast, Northern Ireland September 9, 2010
Process Validation and Verification, MEDTEC Japan 2010 Yokohama Japan April 15, 2010 — invited speaker
FDA’s Increased Emphasis on Supplier Controls — Are You ready? Compliance Online Webinar April 29, 2010
FDAs New Emphasis and Scrutiny of Supplier Controls — What Suppliers to Medical Devices Need to Know Society of Plastic Engineers MiniTec, Claymont, DE October 29, 2009
Effective Design Transfer: Perspectives from Industry Experts Session Chair: MD&M West 2009 Anaheim CA February 12 2009, MDM East June 10, 2009 and MDM Minneapolis October 22, 2009 Full Day Session
Process Validation: Identifying and Controlling Critical Parameters Training for Pharmaceutical Companies March 9 and 19 2009, Hyderabad, India
Effective Risk Management: Practical Methods and Tools — Training for Pharmaceutical Companies March 9 2009 Hyderabad, India
Practical Process Validation Parts 1 and 2 ComplianceOnline Webinar January 15 and 29, 2009,
Gage R&R — Improving the Reliability and Reducing the Variation of Your Measurement System ComplianceOnline Webinar December 11, 2009
Test Method Validation Basics ComplianceOnline Webinar November 24, 2008
What are DHF, DMR, DHR? The FDA Medical Device Regulation Records ExplainedCompliance Online Webinar October 30, 2008, April 2010
Medical Plastics — Future Needs from the Voice of the Medical Device ManufacturerMedical Grade Polymers Conference sponsored by AMI, Philadelphia, PA September 16, 2008
Critical Material Considerations for Medical Devices, Medical Device and Manufacturing West (January 2008) and East (June 2008)
Design for Six Sigma for Medical Devices: Integration with FDA Quality Systems Regulations, Compliance Online Webinar July 19, 2007; August 31, 2006
Designing in Quality via Statistical Process Controls, Compliance Online Webinar, June 27, 2007
Critical Parameters and Design, Process and Purchasing Controls, Compliance Online Webinar April 25, 2007
Nanoadditives: Functional and Property Enhancements of Fibers for Medical Applications Medical Textiles Conference, March 22, 2007 Greenville, SC
Nanoadditives in Composites and Coatings for Medical Device Applications, Medical Device and Manufacturing Conference, February 12, 2007 Anaheim, CA
Successful Implementation Strategies of Design for Six Sigma, Compliance Online Webinar, September 28, 2006
Integrating Design for Six Sigma, Product Development and the FDA/ISO Quality Requirements Medical Device Conference, Institute of Validation Technology, San Francisco August 17, 2006
Plastic Materials in Medical Devices Technologies, Trends and Applications Requirements Medical Device Conference, Institute of Validation Technology, San Francisco August 17, 2006
Design for Six Sigma and New Product Development — SPE eLive Webinar August 3, 2006
Developing Robust New Products Using Design for Six Sigma — Medical Device and Manufacturing Conference New York City, June 7 2006 (Full day workshop)
Robust New Products Using Design for Six Sigma — Canon MedDev Webinar, April 26 2006
Developing Robust New Products Using Design for Six Sigma MEDTEC Conference, Stuttgart, Germany March 9, 2006
Nanoadditives in Composites and Coatings — Technologies of the Future for Medical Devices Future Medical Forum, Daytona Beach, FL March 28, 2006
Six Sigma and Design for Six Sigma: Sustainable Quality Solutions, Foss Manufacturing, Hampton, NH October 15, 2004
Six Sigma: A Roadmap to Increased Profits, Trainers Conference, American Society of Training and Development, Hudson Mohawk Chapter, Albany, NY March 21, 2005
Six Sigma: A One Day Overview, Lorman Educational Services, Syracuse, NY January 21, 2005
Advances in Engineering Resins: A Medical Focus, Medical Device and Manufacturing Conference, Anaheim, CA January 10, 2005
Training
Effective Design Transfer: Perspectives from Industry Experts Session Chair: MD&M West 2009 Anaheim CA February 12 2009; MD&M East New York City, NY June 10 2009 Full Day Session
Process validation for the global medical industry – what suppliers need to know
SPE European Conference on Medical Polymers, Belfast, Northern Ireland September 8, 2010
Process Validation: Identifying and Controlling Critical Parameters Training for Pharmaceutical Companies March 9 and 19 2009, Hyderabad, India
FDA Quality System Requirements and Industry Practice — Faculty of Association for the Advancement of Medical Instrumentation London, June 2006, San Francisco June 2007, March 2008; Seattle, WA June 2009; Nashville, TN June 2011
Process Validation Training — Spacelabls Healthcare April 2011
Process Validation and Quality System Regulation Training Bio-Rad Labs January 2011
Quality System Regulation and CAPA training — Baxter Healthcare May 2010
Effective Risk Management: Practical Methods and Tools — Training for Pharmaceutical Companies March 9 2009 Hyderabad, India
Process Validation Basics, Arrow / Teleflex Medical 2008, Angiotech Medical 2008
Design Controls Basics Angiotech Medical, 2008
How to Comply with the FDA Quality Systems Regulations and Pass FDA Inspections (for pharmaceuticals and medical devices) — MetricStream, Bangalore, India November 2007
Six Sigma Green Belt training — Sun Chemical Corp. 2006, 2007, 2008
Design for Six Sigma training — Sun Chemical Corp. US, Europe 2006, 2007, 2008, 2009
Design for Six Sigma, Ashland Specialty Chemical Co., US, Europe and China 2004, 2005, 2006, 2007
Project Management Training, Ashland Inc., Dublin, OH 2006, 2007
Six Sigma — PolyChem Alloy, Lenoir NC, 2004
Design for Six Sigma, The Valvoline Company, Lexington KY, 2004, 2005
Design for Six Sigma, Becton Dickinson, Franklin Lakes NJ, 2004, 2007
Books, Publications & Patents
Plastics In Medical Devices: Requirements, Properties and Applications, Vinny Sastri Elsevier London. Published in April 2010
PUBLICATIONS
Increased Emphasis on Supplier Controls in the Healthcare Industry. How two companies have responded to the challenge. December 2010
To validate or not to validate? That is the question for plastics processors in the medical device industry. Proceedings SPE European Conference on Medical Polymers, Belfast, Northern Ireland September 9, 2010
Design for Six Sigma: A Company’s Roadmap to Long Term Growth and Sustainability2010
Demystifying Six Sigma, Vision Magazine, Albany-Colonie Chamber of Commerce, January 2009
Design for Six Sigma and Product Development in the Plastics Industry V. Sastri ANTEC 2006 Proceedings , Charlotte NC, May 7-11, pp. 1843-1845 (Awarded best paper by the SPE Product Development Section)
Integrating Product Development Part 2: DfSS and Quality System Regulation V. Sastri Medical Device & Diagnostic Industry pp.56-65 January 2006
Integrating Product Development Part 1: Design for Six Sigma V. Sastri Medical Device & Diagnostic Industry, pp. 62-68, October 2005
Consulting Apps: Selecting Products for Development, V. Sastri Consulting to Management 15(4), 38-39 (2004)
(and 15 others)
Please visit the Articles page of this website to read some of the Dr Sastri’s interviews and articles.
PATENTS
Six patents