|
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 |
|
|
Agenda:
Tuesday,
April 5 |
|
Pre-Conference Workshops |
|
7:30-8:30 |
Registration & Continental
Breakfast |
| 8:30-11:30 |
WORKSHOP A
- AM HALF DAY
CAPA-
Management and Executive Responsibility
Instructor:
John Malloy, John Malloy &
Associates |
|
12:00-1:00 |
Luncheon
for workshop participants |
|
1:00-4:00 |
WORKSHOP B - PM HALF DAY
Software Validation
Instructor:
Armin Torres,
Qualified Data Systems |
|
4:00 |
Workshops Conclude |
Wednesday,
April 6 |
|
Conference
Day One |
|
7:30-8:30 |
Registration & Continental
Breakfast |
|
8:30-8:45 |
Chairman's Welcome
& Opening
Remarks
Ernest
Carabillo, Conference Chairman, Founder, Expertech
Associates |
|
8:45-9:45 |
KEYNOTE ADDRESS
FDA's Outlook for Quality in
Device Manufacturing
Timothy
Ulatowski,
Director, Office of Compliance, Center for Devices and
Radiological Health, US Food and Drug Administration |
|
9:45-10:30 |
Strategies to Prepare
for and Field an FDA Inspection
Mark Brown,
Partner, King & Spalding LLP |
|
10:30-10:45 |
Refreshment Break |
|
10:45-11:30 |
CE Marking for Medical
Devices—Basic Steps to Compliance and Regulatory Update
Rene van de Zande,
Emergo Group, Inc. |
|
11:30-12:15 |
What's New in
Europe?
Maarten Meulenbelt,
Partner, NautaDutilh, Brussels, Belgium |
| 12:15-1:30 |
Luncheon |
|
1:30
-3:30 |
Interactive Roundtable Discussions - Responding to 483's
Jim Kozick,
Director, Medical Device Compliance Services, Parexel
International LLC |
|
3:30-3:45 |
Refreshment Break |
|
3:45-4:30 |
KEYNOTE ADDRESS
"Organizational Integrity": The Cornerstone in Establishing
World Class Quality in Innovative
Medical Devices
Chris Chavez,
President and CEO, Advanced Neuromodulation
Systems, Inc. |
|
4:30-5:15 |
A Process Approach to Quality
Ed Kimmelman,
Quality Systems Consultant |
|
5:15-7:00 |
Networking Reception |
Thursday,
April 7 |
|
Conference
Day Two |
|
8:00-9:00 |
Continental Breakfast |
|
9:00-10:00 |
KEYNOTE ADDRESS
Medrad's Performance
Excellence Journey
Julio Rivera,
Senior Vice President, Corporate Compliance, Medrad, Inc.
Medrad is a
2003 Malcolm Baldridge Quality Award Recipient |
|
10:00-10:45 |
Risk or
Risky Management of Your Clinical Studies?
Charma Konnor,
Senior Manager/Consultant, Devices
and Drugs, Phoenix Regulatory Associates, LTD. |
|
10:45-11:00 |
Refreshment Break |
|
11:00-11:45 |
How to Gain Optimal
Value from and Overcome the Inherant Problems of Internal Audits
Russ Davies,
Vice President, Regulatory Affairs
and Quality Systems, Smiths Medical |
|
11:45-12:30 |
|
|
12:30 |
Conference
Concludes |
|
Presented by:
&
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