Conference

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.

• Quality System Regulations and Design Controls
• Design transfer definition and intent
• Design transfer and product development processes
• Some key elements of design transfer

ABOUT THE INSTRUCTOR

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.

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Integrating Technology Development with Product Development

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.

• Outline of Technology Development and Product Development processes - how they are similar and how they are different
• Setting product feasibility points during Technology Development - how they relate to product performance requirements
• Integrating Technology Development with Product Development Process
• Key elements for transfer of product into manufacturing elements

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.

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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.

A graduate of the University of Dayton School of Engineering, he is currently responsible for managing large drug delivery and medical device programs for the Tech Group Division of West Pharma.

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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.

• Project Risk Management is an essential tool in design transfer management
• A plan for person-to-person transfer of knowledge should be a part of the integrated project plan, and supports rigorous risk management efforts
• Team ''literacy'' in a standardized project management methodology assures proactive ownership and communication by all team members

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.

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Design Transfer: Blending the QSR with Human Behavior

ABSTRACT

Design transfer requires 1) a technical understanding of the product and manufacturing process and 2) an understanding of human behavior. Each element of the QSR must be considered (e.g. process validation, CAPA, product testing and documentation) along with the implementation of procedures that can be followed and easily documented by the workforce.

ABOUT THE INSTRUCTOR

Dr. Russell Roberson, Ph.D., P.E., Director Global Quality, Magnetic Resonance Imaging, General Electric Healthcare

Russell L. Roberson, Ph.D., P.E. has over 25 years of experience in the medical drug and medical device industry in the areas of engineering, operations, auditing, regulatory and management. Dr. Roberson holds the position of Director Global Quality, Magnetic Resonance Imaging, for General Electric Healthcare and is also an adjunct faculty member at several universities where he teaches and designs graduate and undergraduate courses in the areas of business strategy, management, ethics, quality, operations and statistics. He holds a Ph.D. in Business Administration and Management, a M.B.A, a M.S. in Mechanical Engineering and a B.S. in Agriculture engineering along with American Society of Quality certifications as a Quality Engineer, a Manger of Organizational Excellence, a Quality Auditor and a Six Sigma Black Belt. Dr. Roberson is also a Wisconsin Professional Engineer and a Wisconsin State Quality Award Examiner.