Conference

Wednesday, June 4, 2008
9:00 A.M. - 4 P.M.

ABOUT THE INSTRUCTORS

John Gagliardi, President, Midwest Process Innovation

John Gagliardi has had success over the past 33 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. His career functions have included active involvement in the areas of research and development, quality assurance, operations, process architecture, training, and regulatory affairs. Over these years, John has specialized in building systems in these industries that not only seek compliance but also desire to be "business ready" and realize a profit. "Having a compliant quality system doesn't necessarily mean that your company has effective business systems as well."

Michael S. Heyl, Associate, Hogan & Hartson LLP

Mike Heyl's practice is primarily in the medical device area with an emphasis on post-market enforcement matters. He focuses extensively on post-market compliance issues, including the Food and Drug Administration (FDA)'s Quality System Regulation (QSR), adverse event reporting, and field action requirements. His experience includes assisting in the defense of criminal investigations by the U.S. Department of Justice, conducting internal investigations of alleged violations of federal regulations and corporate codes of business conduct, reviewing and drafting standard operating procedures, assisting clients with import and export issues, conducting regulatory due diligence and assistance with negotiation of corporate mergers and acquisitions and initial public offerings, creating and implementing corrective action plans, and providing general advice on a variety of device-related regulatory issues.

Mike also performs audits for companies to determine their level of compliance with FDA's requirements and assists them in attaining regulatory compliance. Additionally, he is a frequent speaker at medical device seminars and conferences.

Prior to joining Hogan & Hartson, Mike served as Senior Manager of Government Relations for the Synthetic Organic Chemical Manufacturers Association (SOCMA). In this capacity, he represented and advocated the interests of batch and specialty chemical producers before U.S. Congress and numerous administrative agencies. Before joining SOCMA, Michael provided business accounting services to a small health care trade association. He has also been involved with numerous political campaigns, including serving on the advance team of a presidential campaign in 1996.

John Deming, Vice President of Quality, Superior Tube Company, Inc.

John is currently Vice President of Quality for the Superior Tube Company in Collegeville, Pennsylvania. Superior Tube Company is a leader in Specialty Metal Tubing Products serving the Medical, Nuclear, Aerospace and Durable Goods Industries. John has over 17 years experience in Manufacturing, Quality and Reliability Management Systems in a wide range of industries that include, Chemical Batch Processing, Electronic Components, Automotive Electronics Assembly, and Semiconductors. John has held various engineering, consulting and management positions at J. Huber & Associates, Johanson Dielectrics, Johanson Technology, and Ford Electronics / Visteon. Most recently, John spent six years at Lucent Technologies-Microelectronics and Agere Systems as a Product and Program Manager in the Sirius Satellite Radio Business.

John holds a B.S. in Industrial Engineering and Operations Research from Virginia Polytechnic Institute and an M.S. in Industrial Engineering and Management from Oklahoma State University, with emphasis in Quality and Reliability Engineering. John is a member of the American Society for Quality and has served on the Board of Examiners for the Pennsylvania Quality Leadership Awards.