This course provides an introduction to the Food and Drug Administration (FDA) to those who need to have an understanding of FDA to perform their jobs. The course provides a background on the agency, FDA history, FDA organization and a look at how FDA functions divisionally.
Those attending will learn about the various FDA centers and what the center responsibilities are. The attendee will also learn about the FDA review process, FDA submissions, Advisory Committees, FDA clinical trials and FDA compliance activities.
Navigate the FDA
Understand FDA responsibilities
Describe the FDA centers
Describe the FDA review process
Summarize FDA compliance activities
Describe the FDA submissions process
Navigate FDA Advisory Committiees
Those who need to have an understanding of FDA in research, clinical regulatory affairs, quality, and administrative positions
The course will be led by one of the following instructors:
Albert A. Ghignone, M.S., R.A.C.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to the FDA
- FDA History/Background
- FDA Laws/Regulations/Policies/Guidances
- FDA Definitions
- FDA Center: CDER; CBER; CDRH
- FDA Combination Products: FDA Office of Combination Products
Day 2: 8:30 a.m. – 5:00 p.m.
- FDA Activities: FDA Relationships; FDA Meetings; FDA Meeting Preparation; FDA Review Process
- FDA Submissions: CDER (IND, NDA); CBER (IND, BLA); CDRH (510(k), IDE, PMA)
- FDA Clinical Trials: Phase 0; Phase 1; Phase 2; Phase 3; Phase 4
- FDA Advisory Commttees: CDER; CBER; CDRH
- FDA Inspections: GMP; GCP; GLP
Scenario reviews
Discussion
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-090-L01-P. Released: 10/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.