Session Information
AABB Audioconference Series 2014
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Surviving an FDA Inspection: GMP and GTP Considerations
Track
:
Cellular Therapy
Program Code:
144812
Date:
Wednesday, August 20, 2014
Time:
2:00 PM to 3:30 PM
EST
DIRECTOR
:
Salem Akel, PhD, Saint Louis Cord blood bank @ SSM Cardinal Glennon Children Hospital
SPEAKER
(S):
Dr. Salem Akel, PhD, Scientific/Laboratory Director, St. Louis Cord Blood Bank @SSM Cardinal Glennon Hospital
Kathleen Fortune, MT(ASCP), Informatics Analyst, SSM Healthcare
Description
FDA regulations and inspections for HCT/P products can be overwhelming. This audioconference will discuss preparations for inspections, understanding the FDA mindset and surviving the inspection itself.
- Describe tips for inspections days.
- Examine the FDA viewpoint towards HCT/Ps.
- Review the qualifications and validations required by FDA.
| 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.
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