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  Day One

  Day Two

  Day Three


Device Congress Agenda: Preconference
Wednesday, March 29, 2006
Registration and Preconference Symposia - Lowell Hall and Faculty Club

7:30 a.m.

Registration Commences at Lowell Hall, Harvard University

8:30 a.m.

Preconference I: Managing Risk By Getting to the Root Cause for Effective Corrective and Preventive Action (CAPA) - Harvard Faculty Club

Today, most medical product design and manufacturing organizations have a CAPA system in place. Unfortunately, many of these organizations do not have an effective methodology for conducting the actual CAPA investigation, identifying the root cause, and implementing a solution to successfully restore product or process performance. Using case studies, this preconference symposium will present a 7-step investigational methodology that will teach the necessary skills to quickly and effectively identify the root cause of a technical CAPA issue.

    Featured Speaker:
    • Tom Weaver, Quality and Operations Improvement Consultant, Weaver Consulting, Former Vice President, Quality Management, Baxter Healthcare, Chicago, IL
    • Steve Ojala, Ph.D., Global Director, Eli Lilly, Indianapolis, IN
    • Nancy Singer, Esq., President, Compliance-Alliance, Former Special Counsel, AdvaMed, Founder, AdvaMed Medical Technology Learning Institute, Arlington, VA
    • Nan Matthews, President, The Matthews Group, Littleton, CO
    • Frances Akelewicz, Founder and President, Practical Solutions, LLC, Yardley, PA

8:30 a.m.

Preconference II: How to Explain Device Reimbursement to Your CEO - Lowell Hall
The session will explain the basics of coverage, coding, and payment for medical devices. The speakers will then provide techniques to convey this information succinctly to members of the senior management team in medical device firms.

11:45 a.m.

Adjournment of Preconference Symposia/Lunch on Your Own

Device Congress Agenda: Day I
Wednesday, March 29, 2006
Lowell Hall

1:00 p.m.

Welcome and Introductions

John Bentivoglio, Esq.
Partner, King and Spalding
Former Special Counsel for Healthcare Fraud
Chief Privacy Officer, United States Department of Justice
Washington, DC
(Co chair)

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

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

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

1:15 p.m.

What We Know and What We Came to Learn
Professor Miller of the Harvard Law School will utilize the Socratic method to create a dialogue with the attendees regarding why they have come to the Device Congress and what they hope to learn.

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

1:45 p.m.

Advocating for Reasonable Regulation
What does the medical device industry need to accomplish in 2006-2007? If successful, how will this affect individual device manufacturers?

Stephen J. Ubl
President and Chief Executive Officer, AdvaMed
Former Vice President, Legislation
Federation of American Hospitals
Former Special Assistant to Senator Charles Grassley (R-IA)
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

2:30 p.m.

FDA's Opportunities and Challenges in Regulating Medical Device Manufacturers
What challenges will FDA face in 2006? How can medical device manufacturers impact the regulatory process? What is the FDA's relationship with HHS, the White House and the Congress?

Scott Gottlieb, MD
Deputy Commissioner for Medical and Scientific Affairs
Office of the Commissioner
Food and Drug Administration
Washington, DC

3:15 p.m.


3:45 p.m.

CDRH's Enforcement Priorities for 2006 - 2007
What are CDRH's priorities for 2006 and 2007? What types of enforcement actions has CDRH taken? How does the agency decide which actions to take?

Tim Ulatowski
Director of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

4:30 p.m.

CMS Priorities for 2006 - 2007: What Device Innovators Should Know About Medicare Regulation
How will these federal priorities affect reimbursement? What policy requirements are driving the Medicare program in 2006 - 2007?

Carol Kelly, MPA
Director of the Office of Policy
Centers for Medicare and Medicaid Services
Washington, DC
Presentation Material (Acrobat)
Presentation Material (Powerpoint)

5:15 p.m.

Governmental Efforts to Deter Violations Under the Fraud and Abuse Statutes in the Medical Device Industry
What actions has the government instituted in 2005 and 2006? How does the government determine its priorities for enforcement actions?

James Sheehan, Esq.
Associate United States Attorney
US Attorney's Office for the Eastern District of Pennsylvania
Philadelphia, PA

6:00 p.m.


6:15 p.m.

Reception - Harvard Faculty Club

6:45 p.m.

PricewaterhouseCoopers Device Congress Banquet
Harvard Faculty Club

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