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 Requirements for Sponsor to Report Fraud
Upcoming Courses
This course will present the content and discuss the impact of the new FDA draft regulatory amendment to 21CFR312.56 & 21CFR812.46 regarding the sponsor responsibility for review of ongoing investigations and monitoring investigations, respectively. The web seminar will present events leading up to the draft, and include a discussion of what reporting a suspicion of fraud vs. a confirmed case of fraud means, as well as discussion of what is not in the rule that was anticipated.
- Recognize the history of the draft regulation and events leading to the release
- Review the content of the draft related to 21CFR312.56 & 21CFR812.46
- Examine implications on stakeholder activities
- Sponsors/CROs
- Project Mangers
- Medical Writing Professionals
- Regulatory Professionals
- Quality Assurance Personnel
- Data Management Professionals
Jeanne Morris, B.S., MT (ASCP)
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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-10-028-L01-P. Released: 8/10.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
