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CASA/FDA Pharmaceutical Industry Seminar
Sheraton Baltimore North Hotel
Towson, MD
May 20, 2011
Seminar Agenda
| 7:00 am – 8:00am |
Registration/Breakfast |
|
| 8:00 am – 8:30am |
Welcome and Program Overview |
Veronica Moore, CASA President
Melinda Plaisier, Regional Food and Drug
Director, Central Region |
| 8:30 am – 9:15 am |
Part 11, Electronic Records and Signatures |
Brian Belz, Consumer Safety Officer, CDER
Office of Compliance, Division of Manufacturing
and Product Quality |
| 9:15 am – 10:00 am |
Process Analytical Technology Quality by Design |
Vihaker Shah, Consumer Safety Officer, CDER
Office of Compliance, Division of
Manufacturing
and Product Quality |
| 10:00 am – 10:15 am |
BREAK |
|
| 10:15 am – 11:00 am |
Biotechnology Products |
Colleen Hoyt, Consumer Safety Officer,
CDER,
Office of Pharmaceutical Science, Office of
Biologic Products |
| 11:00 am – 11:45 am |
Recalls |
Karen Hirshfield, Director, CDER Office
of
Compliance, Division of Manufacturing and
Product Quality |
| 11:45 am – 1:00 pm |
LUNCH |
|
| 1:00 pm – 1:45 pm |
Supply Chain |
Steven Wolfgang, Consumer Safety Officer,
CDER, Office of Compliance, Division of
Manufacturing and Product Quality |
| 1:45 pm – 2:15 pm |
Process Validation |
Grace McNally, Consumer Safety Officer,
CDER,
Office of Compliance, Division of Manufacturing
and Product Quality |
| 2:15 pm – 3:00 pm |
Positron Emission Tomography |
Frank Perrella, Chemist, CDER, Office of
Compliance, Division of Manufacturing and
Product Quality |
| 3:00 pm – 3:15 pm |
BREAK |
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| 3:15 pm – 4:00 pm |
Field Alert Reporting |
Simonne Quiros, Pharmacist, CDER, Office of
Compliance, Division of Compliance Risk
Management and Surveillance |
| 4:00 pm – 4:45 pm |
Foreign Inspections |
Susan Laska, Director, Foreign Drug
Cadre, Office
of Regulatory Affairs, Division of Field
Investigations |
Moderators: Brooke
Higgins, Pre-Approval Manager, FDA, Baltimore District
Vlada Matusovsky, Pre-Approval Manager, FDA,
Philadelphia District |
Download a copy of the agenda
above in PDF format (15 kb)
Seminar
registration form (PDF 15 kb)
Use the form below to securely submit your payment with your
PayPal account or a credit card.
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