KEYNOTE ADDRESS:
FDA's Outlook for Quality
in Device Manufacturing
> Timothy A. Ulatowski
Director, Office of Compliance,
Center for Devices and Radiological Health
US Food and Drug Administration

The Office of Compliance, Center for Devices and Radiological Health, FDA continues its efforts towards improving quality by focusing upon employees, processes, and our customers or stakeholders. Training and development of employees has transitioned to a coordinated effort to improve staff competencies at all levels. The internal quality system has been reinvigorated and we are driving towards systematic, disciplined control of our processes. The office is constantly working to achieve better quality in and timeliness of our products. We have reorganized some key functions, focused our decisions based on critical data and risk analyses, and are optimizing our resources all in an effort to help ensure the public health. Mr. Ulatowski will provide an update on the FDA’s outlook for quality in device manufacturing.

About Tim Ulatowski:
Timothy A. Ulatowski is the Director, Office of Compliance, Center for Devices and Radiological Health. He manages four divisions tasked with promoting consumer health and safety, promoting product quality, and enforcing the medical device and radiological health laws and regulations. Mr. Ulatowski has been with FDA since 1974, and with the Office of Compliance since January 2003.

Prior to his recent appointment he was Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices. He served as the U.S. government representative for Study Group 1 (Premarket) of the Global Harmonization Task Force and on several cross-cutting FDA committees dealing with such topics as reuse of single use devices, user fee implementation, and international standards implementation.

Mr. Ulatowski holds a B.S. degree in Microbiology with honors from the Pennsylvania State University with additional undergraduate study in engineering and computer science, and an M.S. degree in Biomedical Engineering from Georgetown University School of Medicine in consortium with Catholic University, Department of Engineering.

KEYNOTE ADDRESS:
Controlling the Design Process
> Denise D. Dion
Senior Regulatory Consultant
EduQuest, Inc.

Topics covered will include:

• There is no R in Design: Research is not part of design

• Manage the business process of design separate from the control of design

• The Design History File tells your story of your device design

• Tracing requirements is a verification tool

• The yin/yang of design and CAPA - the CAPA subsytem improves design, design provides data to the CAPA subsystem

• Risk Management transcends design

• Marketing helps with design validation

• Design transfer is everyone's responsibility

Common design control problems from Warning Letters and FDA 483s will be used to illustrate key points where applicable.

About Denise D. Dion:
Denise D. Dion, formerly with FDA’s Office of Regulatory Affairs, Division of Field Investigations, is Senior Regulatory Consultant at EduQuest, Inc. She currently provides guidance regarding good manufacturing practices, quality systems, risk management, bioresearch monitoring, compliance and validation of computerized systems, product complaints and failure investigations, FDA inspections and enforcement, registration and listing requirements, and requirements for electronic records and electronic signatures. Before leaving FDA in 2002, she was an Expert Medical Device Investigator and served as an Office of Regulatory Affairs headquarters’ authority on inspections and investigations in general and specifically to medical devices. She has performed complex domestic and international inspections of medical device manufacturers and third-party 510(k) reviewers. She was a member of FDA’s design control inspectional strategy team as well as a core member of the QSIT team and has developed inspection guidance materials and inspection and medical device training for investigators.