Archive: Introduction to the FDA
Jun 1, 2020, 21:50 PM
Course Id :
8196
Barnett Code :
BI10337
Date :
October 25, 2010
Conf Date :
Oct 24, 2010, 20:00 PM
Price :
735.00
Site License Price :
1735.00
This course begins with a comprehensive overview of FDA’s
entire organization, and then drills down into a review of the Drug, Biologic,
and Medical Device Centers. We will look at how each center is organized, how
each center functions, the types of submissions each center reviews, and how
each center conducts the review process.
- Discuss general
information about FDA
- Detail the functions of
the Center for Drug Evaluation and Research (CDER)
- Detail the functions of
the Center for Biologics Evaluation and Research (CBER)
- Detail the functions of
the Center for Devices and Radiological Health (CDRH)
- Discuss the types of
submissions each FDA center reviews
- This course is appropriate
for those who require a general introduction to FDA and how the FDA
centers function, and professionals new to the industry that require an
introduction to basic FDA information and are in Regulatory Affairs,
Clinical, Quality, Manufacturing, Research, Legal, and other departments.
Albert A. Ghignone, M.S., R.A.C.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Sort order :
2010102500000000
topics :
- Clinical Research
- Drug Safety & Development
- Regulatory Compliance
- Research & Statistics
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Investigator
- Regulatory Affairs
- Study Site Compliance
- Training
series :
- Clinical Trials & Translational Medicine
- Drug Discovery & Development
content Id :
101036
urlAliasnm :
Web-Seminar-Archives/Introduction-to-the-FDA-October-2010/