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!
March 2011 Compliance Program Guidance Manual (CPGM) Update: Recommendations for the Inspection of Sponsors, CROs, and Monitors
Upcoming Courses
The FDA released a significant update to the Compliance Program Guidance Manual (CPGM) chapter on Inspection of Sponsors, Contract Research Organizations (CROs), and Monitors (7348.810) in March 2011. This chapter is being revised to incorporate recommendations for improving communications among FDA staff before, during, and after an inspection, and to more clearly define the thresholds for initiating regulatory actions against non-compliant sponsors or CROs. In this web seminar, we will review the changes within the manual, and identify key areas of sponsor activities for audit readiness.
- Navigate the new regulatory climate related to the update to the CPGM: Why the new version?
- Discuss the content of the revised CPGM: What has changed?
- Present the implications of the changes in the CPGM for sponsors/CROs and monitoring: How does this impact how I conduct clinical trials?
- Clinical Operations
- Clinical Research Associates
- Project and CRA Managers
- Sponsors/CROs
- Clinical Quality Compliance and Quality Assurance Professionals
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
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#: 0778-0000-11-077-L01-P. Released: 8/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.
