Inspections-Summit-2012-Agenda
PRE-CONFERENCE WORKSHOPS – Wednesday, Sept. 19, 2012 |
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12:00 p.m. – 1:00 p.m. |
Registration |
1:00 p.m. – 4:00 p.m. |
Drugs and Biologics: Are You Gambling with Your Next Inspection? Improving the Odds of a Favorable Outcome Attendees will learn:
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1:00 p.m. – 4:00 p.m. |
Medical Devices: Back to the Drawing Board — Overhauling Your Complaint Compliance System Attendees will learn the answers to these questions:
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1:00 p.m. – 4:00 p.m. |
Clinical Trials: Beyond Pregnant Males — Understanding and Achieving Quality in Clinical Research Data Attendees will:
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Plenary and Tracks – DAY ONE – Thursday, Sept. 20, 2012 |
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8:00 a.m. – 8:45 a.m. |
Registration and Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Opening Comments |
9:00 a.m. – 10:00 a.m. |
FDA’s Focus on Enforcement and Compliance Attendees will learn:
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10:00 a.m. – 11:00 a.m. |
FDA and the 2012 U.S. Presidential Election Attendees will learn:
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11:00 a.m. – 11:20 a.m. |
Refreshment Break |
11:20 a.m. – 5:00 p.m. |
Three Concurrent Breakout Tracks
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5:00 p.m. – 6:30 p.m. |
Networking Reception |
Drug & Biologics Track |
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11:20 a.m. – 11:30 a.m. |
Moderator Comments |
11:30 a.m. – 12:15 p.m. |
Organizational Structure of the FDA – Emphasis on the Office of Regulatory Affairs (ORA) and Field Operations Attendees will learn:
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12:15 p.m. – 1:00 p.m. |
Preparing for FDA and EMA Clinical Safety and Postmarketing Pharmacovigilance Inspections: Forewarned is Forearmed Attendees will learn:
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1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
EU and US Inspectional Approach for Data Integrity — The Cornerstone for Future Inspections Attendees will learn:
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2:45 p.m. – 3:30 p.m. |
From the Trenches: How to Survive FDA Preapproval Audits Attendees will learn:
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3:30 p.m. – 3:45 p.m. |
Refreshment Break |
3:45 p.m. – 5:00 p.m. |
Panel Discussion: The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on Site to Conduct an Inspection |
5:00 p.m. – 6:30 p.m. |
Networking Reception |
Medical Device Track |
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11:20 a.m. – 11:30 a.m. |
Moderator Comments |
11:30 a.m. – 12:15 p.m. |
Back to Basics on What Comprises the Device History Record – Addressing the Sneaky Requirements Attendees will learn:
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12:15 p.m. – 1:00 p.m. |
How to Effectively Present Your Complaint and Adverse Event Files to the FDA and Reduce Your Risk of a 483 Attendees will learn:
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1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
An FDA Investigator’s Perspective in Assuring a Firm's Top Seven Subsystems are in Compliance and Linked Together Attendees will learn:
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2:45 p.m. – 3:30 p.m. |
Best Practices in FDA 483 and Warning Letter Management and Recovery Attendees will learn:
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3:30 p.m. – 3:45 p.m. |
Refreshment Break |
3:45 p.m. – 5:00 p.m. |
Panel: Emerging Concerns for Device and Diagnostic Manufacturers Attendees will learn:
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5:00 p.m. – 6:30 p.m. |
Networking Reception |
Clinical Trials Track |
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11:20 a.m.–11:30 a.m. |
Moderator Comments |
11:30 a.m. – 12:15 p.m. |
Determining What’s Needed to Conduct Successful IND and IDE Studies Attendees will learn:
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12:15 p.m. – 1:00 p.m. |
Part 11 Compliance in the Cloud — Challenges and Complexities of Validated Systems Attendees will learn:
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1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
Recognizing Serious Adverse Events and Complying with the Different Rules That Govern Their Reporting Attendees will learn:
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2:45 p.m. – 3:30 p.m. |
Harmonizing Regulatory Approaches to Clinical Trials to Improve Quality and Compliance Attendees will learn:
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3:30 p.m. – 3:45 p.m. |
Refreshment Break |
3:45 p.m. – 5:00 p.m. |
Panel Discussion: Understanding Proper FDAAA/Title VIII Reporting and Its Inspectional Implications Attendees will learn:
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5:00 p.m. – 6:30 p.m. |
Networking Reception |
Plenary – DAY TWO – Friday, Sept. 21, 2012 |
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8:00 a.m. – 8:45 a.m. |
Registration and Continental Breakfast |
8:45 a.m. – 9:00 a.m. |
Opening Comments |
9:00 a.m. – 10:00 a.m. |
Lessons Learned: How Product Failures, Recalls and GMP/QSR Problems Trigger FDA Enforcement Actions Attendees will learn:
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10:00 a.m. – 10:15 a.m. |
Refreshment Break |
10:15 a.m. – 11:45 p.m. |
Panel Discussion: Beyond Compliance to Quality Attendees will learn:
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11:45 p.m. – 12:00 p.m. |
Closing Comments |
12:00 p.m. |
Conference Adjournment |