A Barnett Interactive Web Seminar offers you a seamless, secure, multimedia learning experience. These live, instructor-led sessions are designed to be highly interactive, and can be attended by individual attendees or groups at one low cost. No travel, no travel expenses, and no time away from the office!
FDA’s Role in Device Safety Inspections
Upcoming Courses
The primary role of the FDA or other regulatory authority is to protect public health and ensure that devices are safe and effective. This is done by systematically reviewing all data to ensure it is valid and obtained under proper conditions. The FDA has authority to conduct inspections according to the Code of Federal Regulations. This web seminar examines the types of inspections conducted by the FDA and the mechanics of the inspection of a device sponsor as well as an investigational site. Participants will learn the most common audit findings and possible regulatory actions. Several FDA Warning Letters will be reviewed to demonstrate the thoroughness of a regulatory review. Tips will be provided for the management of the inspection activities both during and after the inspection.
- Describe the purpose, types, and mechanics of a regulatory inspection at a device company and an investigational site
- Recognize the Compliance Program Guidance Manual used by the Inspectors
- Discuss common audit findings of sponsors and investigational sites and possible FDA actions
- Recognize common ‘dos’ and ‘don’ts’ in the event of a regulatory inspection
- Clinical Research Managers
- Clinical Research Associates
- Regulatory Associates
- Quality Assurance Personnel
- Clinical Study Coordinators
- Principal Investigators
Gary B. Freeman, M.S.
Click here for complete trainer biographies
$695
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-076-L01-P. Released: 8/15.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
