From the Desk of Ernest A. Carabillo , Jr.
Conference Chairman
Founder, ExperTech Associates

Dear Colleague:

Have you noticed that the warning letters delivered recently to medical device firms from the FDA have included statements like:

“Your firm’s internal audits failed to verify that the quality systems…”

“Your firm’s management with executive responsibility failed to review the suitability and effectiveness of the quality system…”

“Your firm failed to establish and maintain adequate procedures for implementing corrective and preventative action…”

“Your firm failed to validate computer software…”

With years of experience in the medical device industry I can tell you that there are preferred techniques for addressing FDA inquiries and observations. There is good advice available on how to think strategically about CAPA, software validation, risk management, internal audits, and how to field an inspection.

The Second Annual Medical Device Quality Congress, being held April 5-7, 2005 in San Diego, California, is an opportunity for you to get the information you need on these important topics. It is my pleasure to invite you to attend and gain the latest thinking from what I’d call a “powerhouse” of conference speakers.

Keynote speeches will be given by Timothy Ulatowski, Director, Office of Compliance, Center for Devices and Radiological Health, U.S. FDA and Julio Rivera, Director of Corporate Compliance, Medrad, Inc. Medrad is a 2003 Malcolm Baldridge Quality Award Winner.

Other notable experts round out the conference faculty, including:

Mark Brown, Partner, King & Spalding LLP - Former Associate Chief Counsel for Enforcement in the Office of General Counsel for the FDA

Russ Davies, Vice President, Regulatory Affairs and Quality Systems, Smiths Medical - Russ has provided a leadership role in implementing several quality management systems to meet European and US regulatory requirements within medical device companies.

Charma Konnor, Senior Manager/Consultant, Devices and Drugs, Phoenix Regulatory Associates, LTD - Directed regulatory and compliance issues for 25 years at the FDA.

John Malloy, John Malloy and Associates - Internationally recognized expert consultant formerly with FDA

Maarten Meuhlenbelt, Partner, NautaDutilh, Brussels, Belgium - Maarten has extensive litigation experience in the EC Commission. He is recommended in European Counsel's Life Sciences Industry Report.

Armin Torres, Certified Software Quality Engineer, Qualified Data Systems, A Division of BioTeknica - Armin held responsibility for Total Quality Management of in-process quality control inspection, test, and engineering for coronary pacemaker manufacturer and  has developed process validation standards and training programs.

We are all prepared to deliver up-to-date, quality and regulatory intelligence. Please join with me and your peers in industry to share expertise and experiences, to discuss approaches that can be put into practice immediately, and to return to our organizations with the latest news affecting our industry.

Best Regards,

Ernest Carabillo
Conference Chairman