Auditing Risk Management Processes

This presentation will describe the methods and best practices to audit a companies' risk management system. There will be an overview of a lifecycle risk management system and a review of processes to identify during an audit.

F. David Rothkopf, President MEDIcept

F. David Rothkopf has 20 years of professional strategic experience in the development and regulatory control of medical devices. He is the President and Co-Founding Principal at MEDIcept; established in 1996 to offer engineering, manufacturing, quality, and regulatory consulting assistance to the medical device and plasma industry. David’s expertise includes technical and hands-on knowledge in a variety of regulatory, management, and quality processes. He has performed well over 175 ISO 9000, ISO 13485 and FDA-style audits. He and MEDIcept have submitted over 37 PMAs and 510ks. He has trained many medical companies and the FDA on the intricacies of Design Control, risk management and hazard mitigation throughout a product life cycle. He has taught classes at RAPS, ASQ, and SQA annual meetings. In addition to being President of MEDIcept Inc., David is President of SON Medical, a medical software consulting firm and has been instrumental in starting three medical device companies. Mr. Rothkopf holds both a Bachelor and Master of Mechanical Engineering degree from WPI in Massachusetts and an MBA from Boston University.

A Serious (and not so serious) Review of Statistical Tools and Analysis

Discussion will focus on important and popular statistical tools and how they can be misused.

David Cromwick, WW Director of Quality for BDOS

David Cromwick, is the WW Director of Quality for Becton Dickenson, where he is responsible for world-wide quality for the Ophthalmic Division.  Mr. Cromwick started his career at the FDA Winchester and Analytical Center and has worked for several medical device companies in both regulatory and quality roles with increasing responsibility.  He has also provided consulting services for various companies.  Prior to BD, Mr. Cromwick was the Director of Quality and Regulatory at ACT Medical, a contract design and manufacturing house, which was acquired by MedSource Technologies, Inc.  Mr. Cromwick received an MBA from the University of Massachusetts (Lowell) in 1993, his CQE in 1990, and a bachelor’s degree in Mechanical Engineering from Columbia University in 1980. 

Why, Where and How to apply FMEA/FTA during New Production Introduction (NPI) Process

This talk focuses on the importance of FMEA/FTA during NPI process. Case study, software and experience will be shared to reflect the importance of FMEA/FTA, general misgivings behind application of FMEA/FTA and strategies to benefit from their implementation during NPI process.

Nihar Senapati, Reliability Engineering Leader, GE Healthcare

Nihar Senapati is a Reliability Engineering Leader with GE Healthcare in Lawrence, MA. He works in hardware and software Reliability areas. He holds a MS in Reliability and Quality engineering from University of Arizona, Tucson, Post-Graduate Degree in Industrial Engineering and BS in Mechanical Engineering from India.

He is also a CRE, CQE, CSQE and a Six Sigma Black Belt from ASQ. He has consulted and published many papers on various aspects of Reliability, Quality and Six Sigma process improvement initiatives. Nihar is a member of ASQ and IEEE Boston Reliability Chapter.

The Structured Testing Methodology for Software Quality Assurance

Systematic software quality analyses with McCabe’s, Halstead’s and Object-Oriented metrics have been used in improving the design and testing strategies for two networking systems: Carrier Networks Support system that provides services of conventional Layer-2 switches and Layer-3 routing and control services; and a system for providing various networking services (IP-VPNs, Firewalls, Network Address Translations, IP Quality-of-Service, and Web steering). Comparing different Code Releases, it is found that the reduction of the code complexity leads to significant reduction of the errors and maintainability efforts.

Vladimir V. Riabov, Ph.D, Professor, Dep’t of Mathematics & Computer Science, Rivier College

Vladimir V. Riabov, professor of Computer Science, teaches Networking Technologies, Software Engineering, and System Simulation and Modeling at Rivier College. His research interests include Complexity Code Studies, Networking Software Test Strategies, Object-Oriented Embedded System Design, and Computational Algorithms. Vladimir received a Ph.D. in Applied Mathematics and Physics from Moscow Institute of Physics and Technology and M.S. in Computer Information Systems from Southern New Hampshire University. He is a member of ACM, AIAA, IEEE, and MAA.

Rapid DMAIC Deployment

The economy is down, but your company’s continuous improvement efforts should be up.  The current financial situation requires a rapid response to problems and process improvement cycle times.  Well selected projects that are launched properly can be analyzed and improved quickly to address critical business issues.  We’ll review the approach and the share results of some case studies with the audience.

Rui Coelho, Sr. Manager Operational Excellence, OEX Site Leader, Biogen Idec.

Rui has over 20 years of management experience applying various product and process improvement approaches to product design, manufacturing operations and office environments in multiple industries.  Currently he is the Senior Manger of Operational Excellence, OEX Site Leader, at Biogen Idec. Previously he was the Master Black Belt for the Boston Scientific’s Corporate Lean Six Sigma Office.  He also served as Director of Quality and Six Sigma MBB for three Honeywell divisions, and Director of Quality at Black & Decker.  

He is an ASQ Certified Quality Manager and Quality Engineer, and a Honeywell certified Six Sigma Black Belt.  He has an MBA from Rensselaer Polytechnic Institute concentrating in Human Resource Management, and a BS degree in Chemical and Materials Engineering from University of Connecticut.