MDQC 2010 Agenda

FRIDAY, JUNE 4, 2010

8:00 a.m. – 8:45 a.m.

Continental Breakfast

8:45 a.m. – 9:00 a.m.

Welcome and Introduction by Chairperson Ed Bills, Principal Consultant, Bilanx Consulting LLC

9:00 a.m. – 9:45 a.m.

Managing Operations Effectively: Deliver Quality Devices and  Always Be Audit Ready
As the FDA’s field staff continues to grow, that long overdue inspection is more likely than ever to occur. In alignment with Dr. Hamburg’s presentation on enforcement in August 2009, FDA will be prepared to effectively follow-up and act on potentially volatile situations to reassure the public that they are providing the public health protection they expect
and deserve.

Attendees will learn:

  • 5 key elements to have in place to control your manufacturing processes
  • How to build an effective CAPA system to take corrective action quickly when a problem arises
  • How to create an effective listening system to know how your product is performing and the steps to take when something goes awry

Steven Niedelman, Senior Consultant, Crowell & Moring LLP

9:45 a.m. – 10:30 a.m.

Medical Device Recalls: Unique Challenges and Opportunities
No company enjoys conducting recalls and most view them as a necessary evil. Done efficiently and effectively, however, even a product problem can give your company an opportunity to demonstrate high quality standards and concern for customers. A well-developed and tested methodology for conducting recalls is an important first step.

Attendees will learn:

  • The best ways to turn a problem into a unique opportunity
  • A successful and efficient model for recall decision-making that will satisfy the FDA
  • How to assure the effectiveness of recalls — three steps to make it happen quickly

Patricia Shrader, Senior Vice President, Corporate Regulatory and External Affairs, Becton Dickinson

10:30 a.m. – 10:45 a.m.

Refreshment Break

10:45 a.m. – 11:30 a.m.

Closing the Loop on Corrective and Preventive Action (CAPA): A Call to Action
CAPA problems continue to be one of the most cited FDA Form 483 deficiencies generating the single largest number of warning letter citations. This session will discuss the importance, requirements, and elements of a best in class CAPA program, as well as describing how to use CAPA data to help mitigate risk and drive quality in a holistic manner.

Attendees will learn:

  • New and updated regulatory requirements and expectations – including GHTF quality ystems and CAPA guidance
  • How to implement a repeatable, standardized, and complete process that can tackle CAPAs and ensure compliance
  • The importance of developing closed-loop systems that detect existing potential quality problems and facilitate rapid problem resolution and closure

Nancy Duarte-Lonnroth, Director, Quality & Compliance, Healthcare, Celestica

11:30 a.m. – 12:15 p.m.

Beyond Compliance: Advancing Product Quality and Delivering Business Value

Manufacturers that adopt a closed-loop approach to product quality – rather than maintaining their traditional compliance-focused processes – are able to drive business value from: good quality processes, early detection and prevention of issues, the visibility to quickly find and correct root causes, and enforcement to drive consistency across all plants.

Attendees will learn:

  • How Terumo’s strategy drives continuous improvement in its complex global manufacturing processes and quality systems
  • How to turn FDA regulations into an impetus for proactive business decisions that enable higher product quality, growth and profitability
  • Industry benchmarks that show positive business results of embracing a closed-loop approach
Mark Lincoln, Vice President of Operations, Terumo Cardio Vascular Systems
Karim Lokas, Vice President of Product Strategy, Camstar Systems, Inc.

12:15 p.m. – 1:15 p.m.

Lunch Break