Conference Program

Wednesday, September 24, 2008

301 a.m. - Medical Device Design Transfer as a Process 301 p.m. - Software Validation for the Non-Software Engineer: Quality, Design, Development, and Manufacturing System Software

301 a.m. - Medical Device Design Transfer as a Process Instructors: David Vogel, PhD, Founder and President, Intertech Engineering Associates; and Robert Barrett, Lead Systems Engineer, Intertech Engineering Associates; Sam Onukuri, Ethicon Endo-Surgery, Inc. and invited industry speakers Defining the Problem Production Specifications: How much is too much – how little is too little? Borrowing Techniques from Software Design and Validation Define these terms, describe how concepts can apply to design transfer Planning, Lifecycles, Identifying Requirements, Designing, Implementing, Testing & Validation, Risk Management, and Configuration Management Developing a Design Transfer Process Example of a Design Transfer Process How to plan it How to document it How to know if it is working What to do if it isn’t Special Considerations for Outsourced Production Why is outsourced production different How to mitigate risks identified with outsourcing Dealing with Legacy and Acquired Products Defining the problem How does lifecycle apply to these devices Developing Design Transfer Processes for these “not so special” situations 301 p.m. - Software Validation for the Non-Software Engineer: Quality, Design, Development, and Manufacturing System Software Instructors: David Vogel, PhD, Founder and President, Intertech Engineering Associates; and Robert Barrett, Lead Systems Engineer, Intertech Engineering Associates; and invited industry speakers Regulatory background and requirements for validation of quality system software Coverage of the FDA Guidance(s) related to quality system software validation Components of Validation • How to determine if software is regulated or not Using risk management to drive your validation efforts • How to determine how much validation is recommended Dealing with off-the-shelf, custom, and hybrid software packages Validation of Part 11 software

A complete conference brochure PDF is available by clicking here

ABOUT THE INSTRUCTORS

David Vogel, PhD, Founder and President, Intertech Engineering Associates

David Vogel, Ph.D. is the founder and president of Intertech Engineering Associates Inc., of Norwood, Massachusetts. Founded in 1982, Intertech has served the medical device industry by providing electronics hardware and software development services. Dr. Vogel and his Intertech engineering team have developed engineering processes that facilitate product design compliance with FDA Quality System Regulations (QSR). The product verification and validation services provided by Intertech have had a 100% safety record. Dr. Vogel received a BS in electrical engineering from M.I.T. He earned a master's degree in bioengineering, a master's degree in electrical and computer engineering, and a doctorate in biomedical engineering from the University of Michigan.

Robert Barrett, Lead Systems Engineer, Intertech Engineering Associates

Robert E. Barrett is a Lead Systems Engineer with Intertech Engineering Associates, Inc., (www.inea.com) in Northern Illinois , with a 20 year progressive track record of leadership, teamwork and results focus, in the areas of software embedded medical device design, systems engineering, quality management and project management. Robert has also spent 18 years with Baxter Healthcare Inc. gaining management experience in a matrix based organization supporting multiple project and process initiatives. Intertech is an outsource engineering service provider to the medical device industry providing services related to product development and validation, validation of quality and production software, training, and management consulting.

Sam Onukuri, Ethicon Endo-Surgery, Inc

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