ABSTRACT

This session will walk through a full scale process validation using an interactive class exercise through out the session. Attendees will design, develop and validate a process using protocols, sample sizes and acceptance criteria. The results from the validation will be used to develop raw material and process specifications, acceptance criteria, quality metrics and a simple Device Master Record. The inter-relationships between design, process, raw materials, procedures and risk will be emphasized.

Morning:

• Identifying critical parameters using Design of Experiments
• Developing and executing protocols for an Installation Qualification (IQ)
• Developing and executing protocols for an Operational Qualification (OQ)
• Results and Outputs from an OQ (process and material tolerances)

Afternoon:

• Developing and executing protocols for a Performance Qualification (PQ)
• Product and Process Capability calculations and assessments from a PQ
• Results and Outputs from PQ (identifying material and process specifications)
• SPC and SQC; calculating control limits; significance of control limits
• Populating a Device Master Record (DMR) from Process Validation
• Failure Modes and Effects Analysis and identifying risk controls
• Plans and actions to maintain a validated state

ABOUT THE SPEAKERS

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.

Grant Benjamin, Lead Consultant, Medical Product Consultants

Mr. Benjamin has worked in the medical device and pharmaceutical industry for over 25 years. He has lead over 15 technology transfers, and has extensively studied the critical success factors in over 30 other transfers across an array of companies.