InspectionSummit2010Agenda
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration/Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Opening Comments |
9:15 a.m. – 10:00 a.m. |
Understanding FDA’s Findings and Warnings…and Steps to Preclude them from Happening
|
10:00 a.m. – 11:00 a.m. |
FDA’s Focus on Enforcement and Compliance Eric M. Blumberg, Deputy Chief Counsel for Litigation in the Office of the Chief Counsel, FDA |
11:00 a.m. – 11:15 a.m. |
Refreshment Break |
11:15 a.m. – 5:15 p.m. |
Three Concurrent Breakout Tracks
|
5:15 p.m. – 6:15 p.m. |
Networking Reception |
Drug & Biologics Track |
|
11:15 a.m. – 11:30 a.m. |
Moderator Comments |
11:30 a.m.–12:15 p.m. |
Drug Safety and Integrity: Corporate Responsibility in an Era of Globalization
Deborah Autor, Director, Office of Compliance, CDER, FDA |
12:15 p.m. – 1:00 p.m. |
FDA Inspections of Virtual Companies: Requirements and Expectations of Outsourcing
David Chesney, Vice President of Strategic Compliance Services, PARAEXEL Consulting; former FDA District Director for the San Francisco office |
1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
Logistics: Streamlining the Inspection Hosting Process
John Giantsidis, Senior Manager, QA Compliance, AMAG Pharmaceuticals, Inc. |
2:45 p.m. – 3:30 p.m. |
Proven Best Practices for Responding to Form 483s
|
3:30 p.m. – 3:45 p.m. |
Refreshment Break |
3:45 p.m. – 4:30 p.m. |
CBER Inspectional Findings: A Review of Recent Warning Letters
Mary Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA |
4:30 p.m. – 5:15 p.m. |
War Stories: Life on the Front Lines
Vicky C. Stoakes, President, IntegRx, Inc.; former FDA Investigator |
5:15 p.m. – 6:15 p.m. |
Networking Reception |
Medical Device Track |
|
11:15 a.m. – 11:30 a.m. |
Moderator Comments |
11:30 a.m. – 12:15 p.m. |
An FDA Investigator’s Perspective in Assuring a Firm's Top Seven Subsystems are in Compliance and Linked Together
Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District |
12:15 p.m. – 1:00 p.m. |
Lessons Learned: How Product Failures, Recalls and GMP/QSR Problems Trigger FDA Enforcement Actions
|
1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
FDA's Focus on the Regulation of Device Software
Nancy Isaac, Vice President of Regulatory Affairs and Quality, Broncus Technologies |
2:45 p.m. – 3:30 p.m. |
The FDA’s Foreign Medical Device Inspection Program
Seth Mailhot, Counsel, Nixon Peabody LLP; former Compliance Officer and Medical Device Investigator, New England District Office, FDA |
3:30 p.m. – 3:45 p.m. |
Refreshment Break |
3:45 p.m. – 4:30 p.m. |
CDRH’s Compliance and Enforcement Outlook
Larry Spears, Deputy Director for Regulatory Affairs, Office of Compliance, CDRH, FDA |
4:30 p.m. – 5:15 p.m. |
Managing Outsourced Operations for Device Manufacturers: Reducing Risk and Improving Quality
|
5:15 p.m. – 6:15 p.m. |
Networking Reception |
Clinical Trials Track |
|
11:15 a.m. – 11:30 a.m. |
Moderator Comments |
11:30 a.m.–12:15 p.m. |
The Most Common Findings in Clinical Trial Inspections — An FDA Perspective
Stephanie Shapley, Bioresearch Monitoring Specialist, Office of Regulatory Affairs, FDA |
12:15 p.m. – 1:00 p.m. |
Clinical Data Falsification: A Four Letter Word
David Clissold, Director, Hyman, Phelps & McNamara |
1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:45 p.m. |
Conducting Compliant GCP Audits: A Sponsors Perspective
Deborah Waltz, Senior Director, Scientific Operations Quality, King Pharmaceuticals |
2:45 p.m. – 3:30 p.m. |
Inspector's Preparation for a Clinical Inspection — The Protocol and the Science
David A. Lepay, Senior Advisor for Clinical Science, Good Clinical Practice Program, FDA (invited) |
3:30 p.m. – 3:45 p.m. |
Refreshment Break |
3:45 p.m. – 4:30 p.m. |
Harmonizing Regulatory Approaches to Clinical Trials to Improve Quality and Compliance
Ann Meeker-O'Connell, Division of Scientific Investigations, Office of Compliance, CDER, FDA |
4:30 p.m. – 5:15 p.m. |
Build Quality into Device Clinical Trials to Ensure Compliance and Pass FDA Inspections
Michael Marcarelli, Director of Bioresearch Monitoring, CDRH, FDA |
5:15 p.m. – 6:15 p.m. |
Networking Reception |
DAY TWO |
|
8:30 a.m. – 9:00 a.m. |
Registration and Continental Breakfast |
9:00 a.m. – 9:15 a.m. |
Opening Comments |
9:15 a.m. – 10:00 a.m. |
Inspections Beyond US Borders — Inside the ORA's International Operations Branch
Rebecca Ramos Hackett, Director of International Operations Branch, FDA (invited) |
10:00 a.m. – 10:45 a.m. |
Change Control: Current Best Practices for FDA-Compliant Systems
Barbara Immel, President, Immel Resources LLC (Chairperson) |
10:45 a.m. – 11:00 a.m. |
Refreshment Break |
11:00 a.m. – 11:45 p.m. |
“Put Away the PowerPoint” Panel Discussion — What Keeps You Up At Night? Examining the Top 5 Inspectional Concerns of Drug and Device Professionals |
11:45 a.m. – 12:00 p.m. |
Closing Comments |
12:00 p.m. |
Conference Adjournment |