Archive: Introduction to the FDA

October 25, 2010 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

*
*
$735.00

Course Description

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.

Video Preview

 

Learning Objectives

  • 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

Who Should Attend

  • 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.

Instructor

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.