This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.
- Review how new regulatory requirements are being incorporated into inspections
- Discuss the CPGM and rules that support changes in inspection focus
- Assess the FDA’s application of the inspection manual contents as reflected in regulatory communication
- Examine steps for preparation of an inspection
This course is recommended for experienced:
- Professionals from Academia whose institutions or investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators
- Sponsor and CRO Representatives
Elizabeth Ronk Nelson, M.P.H.
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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 2 hours (0.2 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#: 0778-0000-11-074-L01-P. Released: 9/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.