Health Technology Lunch N' Learn- May 13

Description

"Lessons learned in resolving FDA warning letters"
Featuring Mark Neal, VP Global Quality Systems and Assurance, St. Jude Medical

In this presentation, Mark, will describe his experience and lessons learned from numerous FDA inspections and specifically his work to clear five Warning Letters in four FDA Districts.  He will describe how regulatory action is escalated from routine or directed inspections to FDA 483 observations to Warning Letters and the impact of Warning Letters on the business for product approval submissions, design change submission and geography expansion.  Mark will share the high level process for responding to the FDA 483 observations and subsequent Warning Letter (if issued) and will describe the approach to clearing the Warning Letter for specific commitments in the Warning Letter response and the criticality of the re-inspection preparation.  Lessons learned from these experiences will be shared at each stage.  In conclusion, Mark will explain how compliance and quality can be leveraged as a competitive advantage by preventing these types of issues.


About the speaker:

Mark Neal is Vice President of Global Quality Systems and Assurance for St. Jude Medical.  Mark has more than 32 years of experience in all aspects of Quality and regulatory compliance.  He has broad experience in FDA and ISO Registrar/Notified Body interface including FDA inspections, ISO audits, Warning Letter clearance and product regulatory submissions strategy.  Mark has experience in Class I, II and III medical devices, 510(k) and PMA submissions, and with clinical trial requirements.  His career has been predominantly in complex electro-mechanical, software driven embedded systems, associated disposables and applications software in high reliability and human safety critical products from concept to development, distribution and post-market support.  Prior to his current St. Jude Medical role, Mark was Vice President, Quality, Neuromodulation Division.  Prior to St. Jude, Mark led Baxter Healthcare’s Renal Business Design Quality Engineering and Global Service Quality organizations.  Prior to Baxter, Mark served in Quality leadership roles at GE Healthcare, Alcon Laboratories, Adaptec, Abbott Laboratories and Texas Instruments.  At the start of his career, Mark served in the U.S. Army as an Ordnance Corps ammunition and nuclear weapons officer.
 
Mark has a B.S. in Nuclear Engineering from Texas A&M University.  Mark is active in the American Society for Quality (ASQ) where he is a Senior Member and holds certifications in quality management, quality engineering, software quality engineering and quality auditing.  He was Chairman for five International Conferences on Software Quality (ICSQ), sponsored by the Software Division of ASQ.  Mark also is a member of the IEEE.  Mark has published and presented technical papers on quality and engineering topics a number of publications and conferences.  Mark is a founding member and Past Chairman of the Dallas/Fort Worth Association for Software Engineering Excellence.  Mark serves on the Texas A&M University Biomedical Engineering Advisory Board and on the Work Planning and Control External Advisory Board for Sandia National Laboratories.  He and his wife live in the North Dallas area and enjoy traveling and scuba diving.