Why People are Talking About the Medical Device Quality Congress…

“As a repeat attendee, I highly recommend this conference. The workshops, interactive sessions and insights from reputable speakers are very useful and applicable information to take back and share with my company and colleagues.”
Heather Jalisi, Quality Assurance Manager, DexCom Inc.

“I would recommend the seminar in view of strengths of topics discussed and speakers who are well respected in industry.”
Remy Estera, Team Leader, Quality Assurance in Manufacturing, Resmed Ltd. Australia

“It was extremely refreshing to attend a conference with the focus on Medical Devices. Too often with conferences the focus is on drugs. This conference was very well done!”
Joseph Sondej, Associate Manager Quality Control, Celgene Cellular Therapeutics

“One of the most beneficial Congress’ I have ever attended.”
Alejandro Lamas, Quality Assurance Manager, Medtronic Mexico

“Compilation of insightful presentations, covering issues faced by every device manufacturer, presented by industry leaders.”
Chris Lake, Manager Quality Assurance and Regulatory Affairs, Epimed International

Agenda:

Tuesday, May 2
Pre-Conference Workshops
7:30-8:30	Registration & Continental Breakfast
8:30-11:30	WORKSHOP A - AM HALF DAY Complying with FDA and ISO Software Verification and Validation Requirements Instructor: Dennis Rubenacker, Senior Partner, Noblitt & Rueland
12:00-1:00	Luncheon for workshop participants
1:00-4:00	WORKSHOP B - PM HALF DAY CAPA Warning Letter Prevention Instructor: John Malloy, John Malloy & Associates
4:00	Workshops Conclude
Wednesday, May 3
Conference Day One
7:30-8:00	Registration & Continental Breakfast
8:00-8:15	Chairman's Welcome & Opening Remarks Ernest Carabillo, Conference Chairman
8:15-9:15	KEYNOTE ADDRESS FDA's Outlook for Quality in Device Manufacturing Timothy Ulatowski, Director, Office of Compliance, Center for Devices and Radiological Health, US Food and Drug Administration
9:15-10:00	Risk Management - A Complete Life Cycle Approach Harvey Rudolph, Global Program Manager - Medical Devices, Underwriters Laboratories, Inc.
10:00-10:30	Refreshment Break
10:30-11:15	Gaining Value from Implementing ISO 14971/Risk Management for Medical Devices Scott Cohn, QA Compliance, Stryker Orthopaedics
11:15-12:00	Trends in Medical Device Reimbursement Jeffrey Bush, Corporate Director, Reimbursement Becton Dickinson
12:00-1:15	Luncheon Sponsored by
1:15 -2:15	PANEL SESSION Product Recalls Panelists to be announced...
2:15 -3:15	Lessons from Litigation: Utah Medical Products, Inc. and Good Manufacturing Practices Larry Pilot, Partner, McKenna, Long & Aldridge
3:15-3:45	Refreshment Break
3:45 -4:45	Everything You Need to Know About FDA Enforcement Actions Mark Brown, Partner, King & Spalding LLP
4:45-5:30	China Regulatory Compliance for Medical Device Companies - Challenges and Opportunities Chang-Hong Whitney, President, Whitney Consulting Limited
5:30-7:00	Networking Reception Sponsored by
Thursday, May 4
Conference Day Two
7:00-8:00	Continental Breakfast
8:00-9:00	KEYNOTE ADDRESS Controlling the Design Process Denise D. Dion, Senior Regulatory Consultant, EduQuest, Inc.
9:00-9:45	Design Inputs and Design Outputs Harvey Weintraub, Manager Design Control, System Development Core R&D, Abbott Laboratories
9:45-10:00	Refreshment Break
10:00-10:45	Strategies for Effective Medical Device Reporting Debbie Yoder, Nurse Consultant, Reporting Systems Monitoring Branch, Center for Devices and Radiological Health, U.S. Food and Drug Administration & Mary Brady, Deputy Division Director, Division of Surveillance Systems, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration
10:45-11:30	Medical Device Reporting: Problem Solving Exercise in a Team Environment Mike Crader, Vice President Regulatory Affairs, Hill-Rom
11:30-12:15	Ensuring Success in Application Submission and Approval -- Major Considerations in GCP, QSR and GLP Charma A. Konnor, R.Ph., RAC, Senior Manager/Consultant, Devices and Drugs, Phoenix Regulatory Associates, Ltd.
12:15	Conference Concludes