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Management Roundtable| FDAnews

Highlights from last year's conference:

“Excellent forum to meet people from the industry and FDA in a relaxed setting.
Russ Davies, Vice President, Regulatory Affairs and Quality Systems, Smiths Medical, NA

“This conference was very enlightening, especially in trends regarding quality.
Bob Jaksih, Director of Technical Services, Perkins Electronics

...the FDA’s list of recalled devices that could pose serious health problems or death has grown over the last five years, with  18 so far this year...”. 

The Boston Globe, September 1, 2004



Featured Keynote Presentations:
Tim Ulatowski, FDA

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
[read abstract]

"Organizational Integrity": The Cornerstone in Establishing World Class Quality in Innovative Medical Devices
Chris Chavez,
President and CEO,
Advanced Neuromodulation Systems, Inc.

[read abstract]

Julio Rivera, Medrad Medrad's Performance Excellence Journey
Julio Rivera,
Senior Vice President, Corporate Compliance
Medrad, Inc.
2003 Malcolm Baldridge Quality Award Recipient
[read abstract]

You will learn:

  • Up-to-date quality and regulatory intelligence from the experts

  • Preferred techniques for addressing FDA inquiries and observations

  • Critical insight into topics highlighted in recent FDA warning letters

  • What’s new in Europe? Trends in product liability and changes in requirements for QC and technical files

  • How to comply with the CE Marking Directive including ISO 13485

  • Valuable advice on how to think strategically about:

    • Designing and implementing a CAPA system

    • Validating software

    • Preparing for and fielding FDA inspection

    • Responding to a 483

    • Getting the information you need from the internal audit process

    • Managing clinical studies – avoiding data integrity problems and overcoming hurdles to obtaining FDA approval

Chairman's Invitation Letter:

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...

[read more]

Choose from Two Pre-Conference Workshops:

arrowbullet-green.GIF (97 bytes) WORKSHOP A
CAPA - Management and Executive Responsibility
Instructor: John Malloy, President, John Malloy and Associates, Inc.

Find out why last year's participants said:

  • "Best presenter of the seminar!"

  • "This presentation was fantastic. I wish he had a longer time to speak"

  • "Speaker was extremely knowledgeable of the topic." [More Info]

arrowbullet-green.GIF (97 bytes) WORKSHOP B
Software Validation
Instructor: Armin Torres,
Principal, Qualified Data Systems
  [More Info]

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Download Brochure

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Conference Info:

arrowbullet-green.GIF (97 bytes) Register Now
arrowbullet-green.GIF (97 bytes) Agenda
arrowbullet-green.GIF (97 bytes) Workshops
arrowbullet-green.GIF (97 bytes) Keynotes
arrowbullet-green.GIF (97 bytes) Session Descriptions
arrowbullet-green.GIF (97 bytes) Faculty
arrowbullet-green.GIF (97 bytes) About MRT & FDAnews
arrowbullet-green.GIF (97 bytes) Who Should Attend
arrowbullet-green.GIF (97 bytes) Participating Companies
arrowbullet-green.GIF (97 bytes) Become a Sponsor
arrowbullet-green.GIF (97 bytes) Fees & Logistics

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