FDA National Forum – April 30th, 2013, 9am – 4pm
The “Case for Quality Initiative” – Influence the Outcome!
Join your colleagues and FDA leadership for this full day forum to openly discuss one of CDRH’s highest priorities – The Case for Quality Initiative. This initiative, led by Steve Solomon (Director, Office of Compliance) focuses on identifying best practices that will advance product quality across the medical device industry. Includes:
• Full day forum.
• Pre-meeting material from the FDA.
• Post-forum summaries and materials.
• Breakfast, lunch and breaks.
“Compliance is a starting place for high quality products, but it is not the ultimate goal.” – Steve Silverman, Director Office of Compliance, CDRH
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April 30 – May 3, 2013
MedCon (co-sponsored by the FDA and Xavier University) brings the global Medical Device Community together to openly discuss the most pressing issues facing our industry. Hear the most current regulations and legislation affecting the Medical Device Industry, delivered directly from the FDA and Industry experts. Interact with FDA Directors and field investigators to discuss topics such as:
• The FDA Safety and Innovation Act (FDASIA): New requirements and FDA Expectations
• The Case for Quality Initiative: How will this impact you?
• The new 510(k) and PMA guidances, new MDUFA III requirements, the Presubmission Program, QSIT, and top priorities of the ODE
• Tips on how to prepare for the Unique Device Identification final ruling
• A Total Product Lifecycle Case Study by the FDA focusing on Post-Market Surveillance, Risk Management, CAPA, and Design
Don’t miss some of this year’s Key Speakers including:
Conference Keynote Address, Vision for FDASIA – Dr. Jeffrey Shuren, Director, CDRH
Dinner Keynote Address – Congressman Erik Paulsen, Ways & Means Committee
And Many more including:
• Steve Silverman, Director of the Office of Compliance, CDRH
• Christy Foreman, Director of the Office of Device Evaluation, CDRH
• Phil Pontikos, National Device Expert, FDA
• Susan Alpert, Former Senior Vice President, Medtronic
• Gina Brackett, Compliance Officer, Medical Device Specialist, FDA, Office of Regulatory Affairs
• Jay Crowley, Senior Advisor for Patient Safety, CDRH
• Thinh Nguyen, Director of the Office of Combination Products, FDA (Invited)
• Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding
• Phil Phillips, President, Phillips Consulting Group, LLC
• John Barr Weiner, Associate Director for Policy, Office of Combination Products, FDA (Invited)
• Monica Wilkins, Divisional Vice President of Quality Assurance/Regulatory Affairs,
AbbottCopy Link for website and registration: https://www.xaviermedcon.com/enroll/?curtain=0