Click here to go to the previous page
Program Code:
9211-TC-CT
Date:
Sunday, October 25, 2009
Time:
10:30 AM to 12:00 PM
EST
DIRECTOR
:
Donna Regan, MT(ASCP)SBB, Executive Director, St. Louis Cord Blood Bank
MODERATOR
:
Donna Regan, MT(ASCP)SBB, Executive Director, St. Louis Cord Blood Bank
SPEAKER
(S):
Sheryl A. Kochman, MT(ASCP), Supervisory Biologist, FDA
Ellen Areman, MS, SBB(ASCP), Regulatory Consultant, Ellen Areman Consulting, LLC
The Pre-BLA Inspection - Here They Come, Ready or Not!
Description
As a follow up to the preceeding session of the cord blood licensure presentations, this session will focus on specific areas and illustrate how programs can assess practices in their approach toward gaining licensure.
-
Describe a variety of approaches to data management for cord blood banks, including validation and verification requirements.
-
Identify the Centers legal responsibilities when holding a Biologics License Application (BLA).
-
Understand the pre-licensure inspection process.
CE Category | CE Value |
---|
California Clinical Laboratory Personnel |
1.5 |
California Nurse |
1.8 |
Florida Laboratory Personnel |
1.8 |
General Attendee |
1.5 |
Physician |
1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.