Drug and Device Recalls Summit
Drug and Device
Recalls Summit
Bethesda, MD • April 29-30, 2014
Agenda
PRE-CONFERENCE WORKSHOP – Tuesday, April 29, 2014 |
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8:30 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 12:00 p.m. |
Harness the Power of Text Mining — Using the FDA’s Recall Data to Identify and Isolate Root Causes of Nonconformances During this workshop, the instructor will teach attendees, using live FDA data, how text mining can help them analyze FDA data and determine how their products and other products in their class are being reported and if there are trends that show potential problems they may not anticipate. Attendees will learn:
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Plenary DAY ONE – Tuesday, April 29, 2014 |
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12:00 p.m. – 1:00 p.m. |
Registration and Lunch |
1:00 p.m. – 1:15 p.m. |
Opening Comments by Chairperson David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting; former Director of the Office of Enforcement, ORA, FDA |
1:15 p.m. – 2:15 p.m. |
FDA’s Recall Root Cause Research Project Attendees will learn:
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2:15 p.m. – 3:00 p.m. |
How to Recover the Costs of a Recall Attendees will learn:
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3:00 p.m. – 3:15 p.m. |
Refreshment Break |
3:15 p.m. – 4:45 p.m. |
Panel Discussion: How to Master International Recalls Attendees will:
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4:45 p.m. – 6:00 p.m. |
Networking Reception |
Tracks and Plenary Closing Session - DAY TWO – Wednesday, April 30, 2014 |
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8:00 a.m. – 8:45 a.m. |
Continental Breakfast |
8:45 a.m. – 3:00 p.m. |
Two Concurrent Breakout Tracks |
Drugs and Biologics Track |
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8:45 a.m. – 9:00 a.m. |
Track Chairperson Comments |
9:00 a.m. – 10:00 a.m. |
Pharmaceutical and Biologics Recall 2014 Update |
10:00 a.m. – 10:45 a.m. |
Lessons Learned in the Aftermath of Notable OTC Recalls: Understanding the Consequences and Corrective Actions Attendees will learn about:
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10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 11:45 a.m. |
The Role of Regulatory Affairs in Recall Management and Drug Shortage Notification Attendees will learn:
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11:45 a.m. – 12:30 p.m. |
Improving Your Recall Execution Process Attendees will learn:
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12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 3:00 p.m. |
Panel Discussion: Impact Analysis of Recalls — Keys to a Positive Outcome Attendees will learn:
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Medical Devices and Diagnostics Track |
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8:45 a.m. – 9:00 a.m. |
Track Chairperson Comments |
9:00 a.m. – 10:00 a.m. |
Medical Device Recall 2014 Update |
10:00 a.m. – 10:45 a.m. |
Recall Process Lifecycle — SOPs, Preparation and Effective Execution Attendees will learn:
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10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 11:45 a.m. |
Secrets of Successful Recall Termination Procedures Attendees will learn:
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11:45 a.m. – 12:30 p.m. |
Risk Evaluation and Techniques that Meet FDA Standards Attendees will learn:
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12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 3:00 p.m. |
Panel Discussion: Field Corrections vs. Silent Recalls vs. Enhancements Attendees will learn:
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3:00 p.m. – 3:15 p.m. |
Refreshment Break |
PLENARY SESSION PANEL DISCUSSION |
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3:15 p.m. – 4:00 p.m. |
Lessons from the Front Lines: Understanding How to Build Effective Internal Recall Committees Attendees will learn:
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4:00 p.m. – 5:00 p.m. |
Panel Discussion: Recall Trends — Finding the Root Cause Attendees will learn:
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5:00 p.m. – 5:15 p.m. |
Closing Comments by Chairperson |
5:15 p.m. |
Conference Concludes |