Techniques to Engage Top Management in the Quality/Regulatory Function Featured at Medical Device Regulatory and Compliance Congress
  • Benchmarking Your Firm's Practices in Risk Management, Quality Systems, Fraud and Abuse, and Reimbursement
  • Classes Held in Harvard University's Annenberg Hall and Harvard Faculty Club
  • Congress Hotels Sold Out: Overflow Hotels: Sheraton Commander Hotel
  • March 29 - 31, 2006
Phone: 800-684-4549

CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE -- MARCH 7, 2006: The First Annual Medical Device Regulatory and Compliance Congress (Device Congress),, held on the campus of Harvard University March 29 - 31, 2006 will feature techniques to engage top management in the quality/regulatory function.


It's a common problem. Out of the 1024 people replying to Nancy Singer's survey on RA/QA Influence, 37% believed that top management did not appreciate the contribution of the QA/RA function. Out of the 260 firms responding to a new survey on management reviews, one of the most frequently cited challenges was getting top management to schedule and attend the meetings.

At the Medical Device Regulatory and Compliance Congress, a session on specific techniques to engage top management in the quality/regulatory function will include:

  • How to Use a Balanced Scorecard to Explain Key Metrics
  • How to Measure the Cost of Poor Quality
  • Best Practices for Conducting Management Reviews
  • Innovative Ways to Communicate Business and Compliance Risks to Top Management

Nancy Singer, Esq.
President, Compliance-Alliance, Former Special Counsel, AdvaMed, Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA



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Arthur Miller, Esq.
Bruce Bromley Professor of Law
Harvard Law School
Cambridge, MA

"It is my pleasure to welcome attendees of the Medical Device Congress to the campus of Harvard University. I hope that you will take advantage of this unique experience to study key Medical Device Regulatory and Compliance issues."

Special Preconference Sessions:
  • Managing Risk By Getting to the Root Cause for Effective CAPA
  • How to Explain Device Reimbursement to Your CEO
Congress Tracks: Keynote Speakers:

John T. Bentivoglio, Esq.
Partner, King & Spalding, Former Special Counsel for Healthcare Fraud and Chief Privacy Officer, United States Department of Justice, Washington, DC
Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, Food and Drug Administration, Washington, DC
Carol Kelly
Director of the Office of Policy, Centers for Medicare and Medicaid Services, Washington, DC
Michael K. Loucks, Esq.
First Assistant U.S. Attorney, U.S. Attorney, District of Massachusetts, Boston, MA
Jim Sheehan, Esq.
Assistant US Attorney, United States Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA
Stephen J. Ubl
President and Chief Executive Officer, AdvaMed, Washington, DC
Tim Ulatowski
Director of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, Washington, DC
Congress Co Chairs:

George M. Burditt, Esq., Of Counsel, Drug and Device Law Group, Bell Boyd and Lloyd, Chicago, IL

Peter Claude, Partner, PricewaterhouseCoopers LLP, Florham Park, NJ

Richard DeRisio, Vice President, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc., San Antonio, TX

Ron Geigle, Partner, Polidais LLC, Arlington, VA

Robert J. Klepinski, Esq., Of Counsel, Fredrikson & Byron , Former Senior Regulatory Counsel, Medtronic, Minneapolis, MN

Kathleen Lundberg, Chief Compliance Officer, Guidant Corporation, St. Paul, MN

Stephanie Mensh, Former Vice President, Payment and Policy, AdvaMed, Falls Church, VA

Susan Morris, Vice President, Reimbursement Policy and Compliance, Kinetic Concepts, Inc., San Antonio, TX

Robin Strongin, Partner, Polidais, Arlington, VA

Featured Faculty:

Frances Akelewicz, Founder and President, Practical Solution, LLC, Yardley, PA

Paul E. Berger, Publisher,, Merrifield, VA

Willie R. Bryant, Jr. (Invited), NNC Group, Former Senior Recall Officer, Food and Drug Administration, Middletown, MD

Barbara Calvert, Director, Medical Products Reimbursement, Abbott Diagnostics, Washington, DC

Sharon Canner, Vice President, Government Affairs, eHealth Initiative, Washington, DC

M. Weston Chapman, Chairman and Chief Executive Officer, Medical Metrx Solutions, West Lebanon, NH

Norman L. Collazo, Worldwide Director, QA, Cordis Corporation, Miami Lakes, FL

Donald P. Conway, MD, MBA, Director, Healthcare Initiatives, Tuck School of Business at Dartmouth, Assistant Professor, Dartmouth Medical School, Hanover, NH

Gregory de Lissovoy, Ph.D., Vice President and Senior Research Scientist, The MEDTAP Institute, United BioSource Corporation, Bethesda, MD

William T. Fitzgerald, Esq., Director, Global Compliance, Alcon Laboratories, Inc., Fort Worth, TX

Bonnie Handke, RN, Senior Reimbursement Manager, Medtronic, Inc., Minneapolis, MN

Sue Jacobs, Principal Consultant, QMS Consultants, Former Manager of Quality Assurance for Siemens Nuclear Medical Group, Hoffman Estates, IL

Georgia Layloff, Consultant (Former FDA Investigator), Granite City, IL

Nan Matthews, President, The Matthews Group, Littleton, CO

Rita C. McIntyre, RN, RAC, Manager, Customer Quality, Ortho Clinical Diagnostics, Raritan, NJ

Aabed Meer, Co-President, Harvard College Health Policy Society, Managing Editor, Harvard Health Policy Review, Harvard University, Cambridge, MA

Stephanie Mensh, Former Vice President, Payment and Policy, AdvaMed, Falls Church, VA

Michael Mentesana, Director, Pharmaceutical Business Operations, PricewaterhouseCoopers LLP, New York, NY

Ron Milhorn, Former Senior Policy Analyst with Coverage and Analysis Group, Centers for Medicare and Medicaid Services, Managing Partner, Ron Milhorn, LLC, Finksburg, MD

Arthur Miller, Esq., Bruce Bromley Professor of Law, Harvard Law School, Cambridge, MA

Donald W. Moran, Founder and President, The Moran Company, Arlington, VA

Susan Morris, Vice President, Reimbursement Policy and Compliance, Kinetic Concepts, Inc., San Antonio, TX

Judith E. O'Grady, RN, MSN, Senior Vice President, Regulatory, Quality and Clinical Affairs, Integra Lifesciences, Plainsboro, NJ

Steve Ojala, Ph.D., Global Director, Eli Lilly, Indianapolis, IN

Daniel Olivier, President, Certified Software Solutions, Inc., Expert Witness for FDA, San Diego, CA

Parashar Patel, Vice President For Reimbursement and Outcome Planning, Boston Scientific, Natick, MA

Randel Richner, Vice President, Government Affairs and Reimbursement and Outcomes Planning, Boston Scientific, Natick, MA

Brian Riewerts, Senior Partner, Global Pharmaceutical Advisory Services Group, PricewaterhouseCoopers LLP, Baltimore, MD

Noemi Romero-Kondos, Lead Process Manager, Global Complaint Management, Hospira, Lake Forest, IL

Michael J. Ruggiero, Esq., King & Spalding, LLP, Washington, DC

Richard A. Samp, Esq., Chief Counsel, Washington Legal Foundation, Washington, DC

Catherine A. Sazdanoff, Divisional VP, Ethics & Compliance, Abbott Laboratories

Javad Seyedzadeh, Senior Vice President, QA/RA, Bayer Healthcare, Tarrytown, NY

Rosemarie Sweeney, Vice President, Socioeconomic Affairs and Policy Analysis, American Academy of Family Physicians, Shawnee Mission, KS

Stephen Terman, Esq. Partner Olsson Frank and Weeda, Washington, DC

Tom Weaver, Quality and Operations Improvement Consultant, Weaver Consulting, Former Vice President, Quality Management, Baxter Healthcare, Chicago, IL

Greg White, Director of Health Policy, Johnson and Johnson, Washington, DC





For sponsorship and exhibit information contact Joni Lipson, Exhibit Manager, 215-599-6626 phone, 215-545-8107 fax, or at


Register online at, call 800-684-4549, email:

Device Congress Office
7790 Barberry Ave.
Yucca Valley CA USA 92284