ABSTRACT

Of the 74 warning letters issued by the FDA in 2007, 24 or 32% of them contained citations with respect to improper or ineffective process validation. Due to the complexity of many medical devices, routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of the device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated. This one-day session will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation including risk management. An interactive process validation exercise will be used to highlight the principles learned.

Topics covered include:

Morning:

• FDA Quality System Regulations and Process Validation
• Validation Planning and Validation Master Plans
• Process Validation and Design Control
• Risk Analysis
• Validation and Verification
• Installation Qualification (IQ)

Afternoon:

• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Statistical Tools and Techniques
• Sampling Plans
• Process Control
• Maintaining a Validated State
• Validation Life Cycle
• Documentation, Protocols, Reports and Reviews

ABOUT THE SPEAKER

Vinny Sastri, President, Winovia LLC

Vinny Sastri, Ph.D., is the President of WINOVIA LLC. His firm provides customized, sustainable solutions, strategies and training in new product development, quality management and high performance materials for medical device companies. His areas of expertise include design controls, process validation, and FDA and ISO Quality Systems for Medical devices, quality systems and Design for Six Sigma. He consults with medical device companies in designing, developing and manufacturing innovative new products with validated processes and in the implementation of effective quality systems. Prior to starting his own consulting firm, Dr. Sastri has held positions in technology, quality, manufacturing and marketing in companies like BASF, AlliedSignal and General Electric Plastics. Dr. Sastri earned a Ph.D. from Rutgers University, and completed post-doctoral work at Brooklyn Polytechnic Institute. He was also an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. He has published articles in the Medical Device and Diagnostic Industry trade journal, and has given workshops and training on the integration of product development, Design for Six Sigma and the FDA Quality System Regulation in the United States, Europe and Asia.