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Conference, Thursday, October 22
9:00 AM - 4:00 PM (Lunch 12:00 PM - 1:00 PM)
ABSTRACT Effective design transfer is not merely a checklist of activities. It is an organizational process that involves cross-functional teams and key stake holders in transferring a device design to production to ensure the manufacture and release of consistent, safe and effective products and devices. This interactive session will provide attendees diverse perspectives of design transfer from industry experts from different companies. Presentations will cover research and development, product development, operations, quality and contract manufacturing. A panel discussion will allow attendees to ask further questions and interact with the illustrious panel of speakers. Introduction and Design Transfer Overview ABSTRACT Design Transfer is part of Design Controls in the FDA 21 CFR Parts 820 Quality System Regulation for medical devices and is part of Design and Development Planning in ISO 13485:2003 Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes. This presentation will provide a brief overview of Design Transfer as it relates to the regulations and some of its important elements. The overview will set the stage for the rest of the presentations and the panel discussion.
ABOUT THE INSTRUCTOR Dr. 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. Integrating Technology Development with Product Development: Perspectives on The Design Transfer Process ABSTRACT Many companies use the Stage-Gate® process and six sigma concepts for product development. In the medical device industry one key challenge is to incorporate best practices with respect to regulatory and design transfer requirements. At Becton Dickinson we have also adopted a stage gate process for development of new technology processes. An additional challenge then is to look forward at requirements for product development and structure the technology project output to facilitate movement into the commercialization phases. This challenge will be examined with commentary on some best practices, including perspectives on project teams and interaction with sponsoring business units.
ABOUT THE INSTRUCTOR Dr. Jerome Parmer, Ph.D., Director Product Technology/Research and Development, Becton Dickinson Diagnostics — Preanalytical Solutions Jerome Parmer, Ph.D., is currently Director of Product Technology for BD Diagnostics - Preanalytical Systems. He has been with BD for the past six years where he has held multiple positions in R&D leadership for the Preanalytical Systems business. He has extensive experience with technology development, product development, and stage gate processes used to facilitate those areas. Prior to joining BD he was with GE Plastics where he held various positions in product development. He also worked at AlliedSignal (Honeywell) in Corporate R&D and business development capacities. He has over 20 years of experience in the plastics and medical device industries, and is a certified black belt. Elements of an Effective Device Manufacturing Transfer to a Contract Manufacturer ABSTRACT Design transfer is the process of introducing a medical device design to the manufacturing environment. Effective planning and management of the design transfer process to a contract manufacturing organization is critical to efficient and timely market introduction. This talk will cover the key elements of the transfer process from a Contract Manufacturer’s perspective with relevant examples. ABOUT THE INSTRUCTOR Mark McElfresh, Program Director, The Tech Group Mark McElfresh has over 25 years of extensive technical and management experience. Over his career, he has proven his effectiveness in product development, process development, quality assurance, project management, process validation and supervision of technical professionals. He has been involved with leading start-ups of new manufacturing systems and facilities for both large pharma companies and contract manufacturers. He also holds five U.S. Patents and associated foreign patents. Risk Management and Knowledge Transfer — Key Factors for a Successful Design Transfer ABSTRACT Transfer management is risk management. Successful transfer teams actively manage project risks using a structured approach. This presentation will discuss the application of risk management tools in transfer planning and execution, with special focus on the identification and tracking of knowledge transfer.
ABOUT THE INSTRUCTOR Grant Benjamin, Sr. Director, Category Team Leader, Plasma Business, Fenwal Inc. 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. Design Transfer: Real World Examples and Case Studies ABSTRACT Successful transfer from the design phase to manufacturing is critical for an efficient product launch to produce and sell consistent, safe and effective devices. This transfer requires upfront planning throughout the product life-cycle, cross divisional, and interdisciplinary communication, and teamwork. This presentation will compare and contrast real-world industry case studies and examples with varying levels of success involving transfer of products from design to manufacturing. ABOUT THE INSTRUCTOR Michelle Moran, President, ML Moran Consulting, Inc Ms. Moran is the founder and President of ML Moran Consulting, Inc, a consulting firm that specializes in compliance, risk management, and product/process development. She is the author, and/or co-author of numerous industry technical publications, and presentations and has over 20 years of industry experience. Ms. Moran's professional experience has included various positions within Xerox, Bausch & Lomb, Baxter, and Fenwal. Ms. Moran's global cross functional experience spans the full product development lifecycle, from R&D and Product Development Leadership efforts through design and technology transfer, and product commercialization. |
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