Winovia | Quality Management Systems Consulting

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 quality partner for ….

Quality Training for Medical Devices

Winovia provides both open enrollment training and customized in-house training for compliant, self-sustaining quality management systems and processes for medical device manufacturers and their suppliers.

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.

Quality Systems for New Product Development

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.

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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RECENT EVENTS

May 16-19, 2017
Winovia presented the interactive and intensive training ADVANCED PROCESS VALIDATION — PRACTICAL SOLUTIONS AND STRATEGIES FOR THE MEDICAL DEVICE INDUSTRY, in Chicago, IL. Visit the Advanced Process Validation Training webpage for more information. This training was pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification. 

January 1, 2017
Dr Sastri wrote an article for Medical Design Briefs titled Design Validation for Regulatory Requirements.

December 2016
New training courses in 2017 for the Medical Device Manufacturing industry! Courses include Test Method Validation, Advanced Process Validation, and Advanced Design Controls and Risk Management. See the Medical Device Quality Training page for course dates and descriptions.

October 2016
Dr Sastri published the article HOW TO MEET BIOCOMPATIBILITY NEEDS OF POLYMERIC MEDICAL COMPONENTS for the September-October 2016 issue of Asia’s Medical Plastics Data Service magazine, pp. 22-24.

September 21-23, 2016
Dr Sastri and Winovia LLC presented the training Process Validation — Practical Solutions & Strategies for the Medical Device Industry, in Chicago Illinois. This course has been pre-approved by RAPS as eligible for up to 12 credits towards RAC recertification. Visit the Process Validation Training webpage for more information.

May 30 – June 2, 2016
Dublin Ireland
Vinny Sastri was a faculty member for the 4 day intensive program Quality System Requirements and Industry Practice, providing quality system professionals with the basic knowledge and skills needed to develop a quality system program that conforms with the FDA’s Quality System Regulation. This course was a partnership with AAMI and CQT Solutions.

February 23-24, 2016
Washington DC
Vinny Sastri was a speaker and panel moderator at the Risk Acceptability and Life Cycle Management Conference, sponsored by MedTech Intelligence with support from Dentons, MDMA and SGS. This conference brings together a diverse group of industry and FDA experts to address challenges and to share strategies and best practices for the assessment and management of risk in medical device development, market clearance or approval, and postmarket evaluation.

 

Archive of Past Events