MD&M Minneapolis Conference Agenda

Ready to register? Call us for express conference registration - 310-996-9435

Tuesday, October 30, 2012 Each Session runs concurrently from 9:00 A.M. to 4:00 P.M. with a one-hour lunch break
Regulations and Compliance	Quality and Risk Management	Design and Manufacturing Principles	Innovations in Technology
1A Regulatory Pre-Market Submissions Preparing Approval Submissions in Today’s Challenging Regulatory Environment – FDA and International Perspectives Chairs: Lisa Becker, Senior Director Regulatory Affairs, St Jude Medical Michele Chin Purcell, Ph.D., Sr. Director Regulatory Affairs, St Jude Medical	1B Risk Management Workshop Risk Management for Medical Devices: Applying 14971 Effectively Using Risk Assessment and Reliability Tools Chairs: Michael Barile, Founder and Managing Partner, Barile & Associates Andrew Snow, President, Momentum Solutions	1C Human Factors in Design Workshop Integrating Human Factors into Design to Meet Regulatory Requirements and User Needs Chair: Steve B. Wilcox, Principal and Founder, Design Science	1D Material Selection Workshop: Innovations in Medical Materials Effective Medical Device Materials Selection and Case Studies on Smart Materials Chair: Jasmine Patel, Senior Associate, Exponent

Wednesday, October 31, 2012 Each Session runs concurrently from 9:00 A.M. to 4:00 P.M. with a one-hour
Regulations and Compliance	Quality and Risk Management	Design and Manufacturing Principles	Innovations in Technology
2A Post-Market Regulatory Compliance FDA Updates and Top Violations Cited by the FDA, Post-Market Surveillance, CAPA Root Cause Analysis Workshop Chair: Prithul Bom, Director, Global Sales and Marketing, WMDO	2B Risk Management in a Quality System Risk Management: How much is enough? Chairs: Michael Barile, Founder and Managing Partner, Barile & Associates Andrew Snow, President, Momentum Solutions	2C Manufacturing Strategies and Processing Technologies Incorporating Rapid Manufacturing Principles and Technology into the Design Process Chair: Arthur Erdman, Director of Medical Devices Center, University of Minnesota	2D Power Source Technologies in Medical Devices Innovations in Battery Technology and FDA Safety and Reliability Requirements Chair: Gaurav Jain, Research Manager, Medtronic

Thursday, November 1, 2012 Each Session runs concurrently from 9:00 A.M. to 4:00 P.M. with a one-hour
Regulations and Compliance	Quality and Risk Management	Design and Manufacturing Principles	Innovations in Technology
3A Process Validation Workshop Solutions and Strategies: Applying Statistical Methods Throughout Process Validation Chair: Heath Rushing, Consultant, Adsurgo	3B Quality Issues in Design Controls Step-by-Step Guide to Quality Management Using Design Controls from Initial Design Concepts to Design Transfer Chair: Steve Walfish, President, Statistical Outsourcing Services	3C Medical Reliability Testing FDA Requirements and Industry Best Practices for Medical Device Reliability Testing Chair: Mike Silverman, Founder and Managing Partner, Ops a la Carte	3D Implantable and Bio-Electronic Systems Design and Manufacturing Solutions for Developing SOCs, Microprocessors, Sensors, Power Supply, and Wireless Capabilities Chair: Tim Denison, Director of Neural Engineering, Technical Fellow, Medtronic