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Drug Seminar Agenda
NIAGARA FALLS CONFERENCE CENTER
NIAGARA FALLS, NY
MAY 16, 2005
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7:30am – 8:30am |
Registration |
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8:30am – 8:45am |
Welcome and Program Overview |
Beverly Kent, President of the Central
Atlantic States Association of Food and Drug Officials |
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8:45am – 10:15am |
Pharmaceutical GMPs for the 21st Century: The
Risk-Based Inspection Model; Part 11 and the Aseptic Processing
Guides |
Fred
Blumenschein, Director, Case
Management and
Guidance Branch, Division of Manufacturing and Product Quality,
Office of Compliance, CDER/FDA
George Smith,
Compliance Officer, Case Management and Guidance Branch, Office
of Compliance, CDER/FDA
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10:15am – 10:30am |
Break |
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10:30am – 11:30am |
Pharmaceutical GMPs for the 21st Century
(continued) |
Mr. Blumenschein
Mr. Smith |
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11:30am – 12:00pm |
Questions and Answers |
Mr. Blumenschein
Mr. Smith |
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12:00pm – 1:15pm |
Lunch
(provided) |
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1:15pm – 2:15pm |
Importing, Exporting, and Import-for-Export |
Margaret M. O’Rourke,
Senior Regulatory Expert, Imports/Exports/PDMA Team, Division of
New Drugs and Labeling, Office of Compliance, CDER/FDA |
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2:15pm – 3:00pm |
Counterfeit Drugs |
Erik
Henrikson, Special Assistant to the
Director, Division of Manufacturing and Product Quality, Office
of
Compliance, CDER/FDA |
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3:00pm – 3:15pm |
BREAK |
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3:15pm – 4:15pm |
Current Inspectional Issues and FDA Initiatives |
Susan F. Laska,
Investigator, FDA/Philadelphia District Office |
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4:15pm – 5:00pm |
Questions and Answers |
Panel |
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Moderator: Karyn M. Campbell, Assistant Director,
Investigations Branch, FDA/Philadelphia District Chairperson,
CASA Drug Committee
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