C O N F E R E N C E
Quality in
Device Manufacturing: The New Global Profit Center
March 30-31, 2004
/ San Diego, CA |
AGENDA
(subject to change)
Tuesday, March 30 |
|
Pre-Conference Workshop |
|
7:00 |
Registration and Continental Breakfast |
|
8:00 |
Workshop:
Developing Your Quality Systems to Incorporate Global Standards
Instructor: Joe FitzGibbon, Orion
Canada, Inc. |
|
12:00 |
Lunch for workshop participants |
|
12:00 |
Registration for Main Conference |
|
1:00 |
Welcome and Introduction
Ernest Carabillo, Conference Chair |
|
1:15 |
Keynote
The FDA's Outlook for Quality in
Device Manufacturing
Timothy Ulatowski, FDA |
| 2:15 |
How to Prepare for an FDA Inspection: A Practical Perspective
Russ Davies, Vice President Regulatory Affairs and Quality
Systems,
Smiths Medical NA |
|
3:00 |
FDA's Inspection Authority and How to Respond to Troublesome
Requests
Donald Segal, Shareholder, Buchanan Ingersoll |
| 3:45 |
Refreshment Break |
|
4:00 |
Global Medical Devices: What You Need to Know About the CE Mark
Directive and Third Party Audit Process
Brad Amundson, SGS International Certification Services |
| 4:45 |
CAPA: Studies in Litigation
Patrick J. Reda, Litigation Associate, Kenneth B. Moll and
Associates |
| 5:30 |
Panel Discussion I:
Experiences with QSIT/Traditional
Inspections
Panelists: Russ Davies, Patrick
J. Reda, Donald Segal, Ernest Carabillo |
|
6:00 |
Networking Reception |
Wednesday, March 31 |
|
7:00 |
Continental Breakfast |
|
8:00 |
Managing Field Corrective Actions (Corrections and Removals)
Larry Pilot, Partner, McKenna, Long & Aldridge LLP |
|
8:45 |
Design Controls: Management's Tool for Commercial Success
Bob Dicheck, Vice President World Wide Quality and Regulatory
Affairs, Inverness Medical Innovations / Unipath |
| 9:30 |
Refreshment Break |
| 9:45 |
Incorporating Design Controls into a Fast and Flexible
Development Process
Glenn Gerstenfeld, Director of Quality Assurance/Quality Systems
& Jan Wells, Director of Program Management, GMP Companies, Inc. |
|
10:30 |
General Principles and Case Studies in Process Validation
Cal Bowman JD, RAC AQ, CQM, CQA Vice President of Compliance and
Quality, Dow Pharmaceutical Sciences |
|
11:15 |
Compliance at a Fraction of the Cost -- Design Verification &
Product Safety: Industry Benchmarking Study
Paul Adam, Manager, Product Development Productivity, Medrad,
Inc. & Wayne Mackey, Principal, Product Development Consulting,
Inc. |
|
12:00 |
Luncheon
Feature Presentation
The standardization Crutch
John Glaccum, Ethicon Endo-Surgery |
|
1:30 |
Seven Habits of Highly Effective Risk Management Systems
Kevin M. Quinley, CPCU, ARM, AIC, AIM, ARe Senior Vice President
Risk Services, MEDMARC Insurance Company |
|
2:15 |
Managing for Quality - A Value Added Activity (Management
Responsibility for QA)
John Malloy, President, John Malloy and Associates, Inc. |
| 3:00 |
Refreshment Break |
|
3:15 |
Panel Discussion II:
Management Responsibility for QA/RA
Panelists: Cal Bowman, Bob
Dicheck, John Malloy, Ernest Carabillo |
| 4:00 |
Shedding Light on FDA Expectations for Software Validation
Practices
Ronald K. Moy, Associate Director of
Quality, Quintiles Consulting |
| 4:45 |
Close of Conference |
|
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Conference Info |
Hosted by:
&
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