Winovia® LLC is a consulting and training company that provides customized solutions and strategies for organizations to streamline and transform their new product development systems, quality systems and manufacturing processes. We also align organizations’ Quality Management Systems with specific regulations and standards like the US FDA and ISO regulations and standards. Client companies achieve organizational and operational excellence leading to sustained growth and profitability.

Winovia is your expert partner for ….

New Product Development Systems

Winovia can help you assess your New Product Development process, identify weaknesses and strengths, and create and implement a customized system for creating and managing new products through their entire life cycle.

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Operational Excellence & Quality Management

Winovia is your partner for auditing, developing and implementing sustainable and compliant quality systems and manufacturing processes. Winovia’s systems and training result in operational efficiency, productivity and superior quality.

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FDA/ISO Compliance & Quality Systems

Whether you’re new to the market or an established company, Winovia has the expertise to help you develop effective, sustainable and compliant quality systems. Winovia has the knowledge to help you address Warning letters and FDA Form 483s, as well as implement procedures for design control, risk management, complaint handling and CAPA.

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RECENT EVENTS

March 21, 2014
Part of the Quality System Regulation (QSR) Webinar Series, Vinny Sastri presents Production and Process Controls. This webinar provides an overview of why and when production and process controls are required, what end they aim to achieve, how they can be performed, and what monitoring, review, and documentation are needed. Visit the QSR Webinar Series website for more information.

February 20, 2014
Plastics in Medical Devices, Second Edition
is now available. The new edition includes two new chapters on supplier controls and process validation. The book features comprehensive coverage of uses of polymers for medical devices, along with unique coverage of medical device regulatory aspects.
Plastics in Medical Devices, Second Edition: Properties, Requirements, and Applications (Plastics Design Library)

July 18, 2013
Vinny Sastri lead the full day course Process Validation – The Key to Robust Manufacturing and Sustained Product Quality during the Institute of Medical Device Development (IMDD) Training Week in Boston, MA.

June 17-20, 2013
Vinny Sastri was a faculty member for the intensive 4 day program Quality System Requirements and Industry Practice in San Francisco, CA, sponsored by the Association for the Advancement of Medical Instrumentation (AAMI).

June 4-6, 2013
Dr Sastri presented Best Practices in Implementing an Effective Risk Management System at the Tenth Annual Medical Device Quality Conference in Bethesda, MD.

May 16-17, 2013
Vinny Sastri led the seminar Process Validation – Practical Solutions and Strategies for the Medical Device for Compliance Online in San Francisco, CA.

April 15, 2013
Vinny Sastri gave a presentation on Effective Quality Management Systems and Global Competitiveness at the Rotary Club in Bangalore, India. 

March 28, 2013
Vinny Sastri presented The FDA’s Strategic Initiative – Focus on Quality versus Compliance at The March of Quality: North Jersey ASQ Spring Quality Conference in Whippany NJ. 

December 10-14, 2012
Vinny Sastri conducted the AAMI Quality System Requirements and Industry Practice training, as part of the AAMI faculty in Limerick Ireland.

September 25-26, 2012
Dr Sastri was a featured speaker at Medical Grade Polymers,  organized by Applied Market Information (AMI) in Boston, MA.

Archive of Past Events