PRESS RELEASE: The Medical Device Regulatory and Compliance Congress Features Best Practices Quality Track
  • 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: The Inn at Harvard and Harvard Square Hotel, Cambridge, MA
  • March 29 - 31, 2006
Phone: 800-684-4549

CAMBRIDGE, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- JANUARY 5, 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 a special Best Practices Quality Track. The Device Congress is sponsored by AdvaMed, Compliance-Alliance, Harvard Health Policy Review, Health Affairs, Medical Education Collaborative and a variety of leading publications.

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."

Medical Devices: Best Practices Quality Track
March 30, 2006
Morning Session
Moderator: Kathy Lundberg, Chief Compliance Officer, Guidant Corporation
8:30 a.m. Successfully Using a Balanced Scorecard
What is a Balanced Scorecard? What are six keys to its successful utilization? Where do companies experience problems?

  • Sue Jacobs, Principal Consultant, QMS Consultants, Former Manager of Quality Assurance for Siemens Nuclear Medical Group
  • Steve Ojala, Ph.D., Global Director, Eli Lilly
9:15 a.m. Measuring the Cost of Poor Quality
What factors go into calculating the cost of poor quality? How can medical device officials use the data to lobby for more resources for preventive actions?

  • Daniel Olivier, President, Certified Software Solutions, Inc., Expert Witness for FDA
  • Nancy Singer, Esq., President, Compliance-Alliance, Former Special Counsel, AdvaMed
10:00 a.m. Break
10:30 a.m. A Former FDA Investigator's View of Best Practices for Conducting Management Reviews
What are the requirements for compliance and how will they be assessed? What items would be addressed in an optimal management review?

  • Georgia Layloff, Consultant (Former FDA Investigator)
11:15 a.m. Communicating Business, Product and Compliance Risks To Top Management
What are some effective techniques to get the attention of top management? How do you distill the report into language that top management will pay attention to? What are some effective methods of communication?

  • Javad Seyedzadeh, Senior Vice President, QA/RA, Bayer Healthcare
Noon Lunch

Afternoon Session
Moderator: Richard DeRisio, Vice President, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc.
1:30 p.m. Integration of Risk Management and Design Control
How to employ risk management when developing features for safety and profitability? How to employ risk management for efficient design transfer?

  • Frances Akelewicz, Founder and President, Practical Solution, LLC
2:15 p.m. Integration of Risk Management and CAPA
How to use risk management to prioritize corrective and preventive actions? How to use risk management as a predictive indicator?

  • Norman Collazo, Vice President, Quality, Cordis
2:45 p.m. Integrating Risk Management in Complaint Handling
How can you use complaints to improve quality? How can the tools you use to monitor complaints help you evaluate potential risks from your product? When does a complaint mandate that you take corrective action?

  • Richard DeRisio, VP, Quality Assurance and Regulatory Affairs, Kinetic Concepts, Inc.
3:30 p.m. Break
4:00 p.m. Integrated Operations
How are the industry trends driving us toward transformational change? How can integrated operations assist with improving customer service, quality, compliance and risk management?

  • Naomi Romero-Kondos, Lead Process Manager, Global Complaint Management, Hospira
  • Michael Mentesana, Director, Pharmaceutical Business Operations, PricewaterhouseCoopers
4:45 p.m. Using Risk Management to Defend Product Liability Actions
When do you educate the staff on risk management principles? How do you document your risk management decisions?

  • Rita C. McIntyre, RN, RAC, Manager, Customer Quality, Ortho Clinical Diagnostics
5:30 p.m. Adjournment and Networking Reception

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