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After Yes - Navigating the Rules of the Road in Today's Marketplace
Panel Session
Regulatory, Quality and Good Manufacturing Practices
Melissa Torres
Associate Director for International Affairs, Center for Devices and Radiological Health
FDA
Luann Pendy, PhD
Chief Quality & Regulatory Affairs Officer
Medtronic
Thomas Westrick
Vice President and Chief Quality Officer
GE Healthcare
Laila Gurney
Sr. Executive Global Regulatory Affairs
GE Healthcare
Ted Wilson
Partner
Hogan Lovells
This session provides up to date insight on regulatory inspections. Learn about the latest information on ORA re-alignment and improved collaboration between ORA and CDRH. What will this mean to your company, and how can you best prepare for future inspections? What are the current areas of focus for FDA? The session will also cover MDSAP Inspections, which are becoming increasingly popular with companies as word spreads about the value in reducing redundant inspections from a variety of regulatory authorities. Hear from one of the MDSAP pioneering companies, sharing actual experiences as well and “dos” and “don'ts.”