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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 |
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Featured Keynote Presentations:
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FDA's Outlook for Quality in Device
Manufacturing
Timothy A. Ulatowski,[BIO]
Director, Office of Compliance,
Center for Devices and Radiological Health
US Food and Drug Administration
[read abstract] |
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"Organizational Integrity": The Cornerstone in
Establishing World Class Quality in Innovative
Medical Devices
Chris Chavez,[BIO]
President and CEO,
Advanced Neuromodulation Systems, Inc.
[read
abstract] |
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Medrad's Performance Excellence Journey
Julio Rivera,[BIO]
Senior Vice President, Corporate Compliance
Medrad, Inc.
2003
Malcolm Baldridge Quality Award Recipient
[read
abstract] |
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You will learn:
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Up-to-date quality and regulatory intelligence from
the experts
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Preferred techniques for addressing FDA inquiries
and observations
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Critical insight into topics highlighted in recent
FDA warning letters
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What’s new in Europe? Trends in product liability
and changes in requirements for QC and technical
files
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How to comply with the CE Marking Directive
including ISO 13485
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Valuable advice on how to think strategically about:
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Designing and implementing a CAPA system
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Validating software
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Preparing for and fielding FDA inspection
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Responding to a 483
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Getting the information you need from the internal
audit process
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Managing clinical studies – avoiding data integrity
problems and overcoming hurdles to obtaining FDA
approval
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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] |
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Choose
from Two
Pre-Conference Workshops:
WORKSHOP A
CAPA - Management
and Executive Responsibility
Instructor:
John Malloy,
President,
John Malloy and Associates, Inc.
Find out
why last year's participants said:
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"Best presenter of
the seminar!"
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"This
presentation was fantastic. I wish he had a longer
time to speak"
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"Speaker
was extremely knowledgeable of the topic."
[More Info]
WORKSHOP B
Software
Validation
Instructor: Armin Torres,
Principal, Qualified Data Systems
[More Info] |
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Presented by:
&
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