The FDA recently released its much-anticipated Compliance Program Guidance Manual (CPGM) on how FDA investigators are trained to conduct inspections of Institutional Review Boards (IRBs). The completion of this CPGM finalizes the recent updates to the FDA’s approach for inspecting key entities involved in the conduct and/or support of clinical research. This web seminar will review the FDA’s current focus during inspections and the factors driving these changes.
- Review how new regulatory requirements are being incorporated into inspections
- Discuss the new guidance and rules that support changes in inspection focus
- Assess the FDA’s application of the guidance as reflected in regulatory communication
- Examine steps for preparation of an inspection
This course is recommended for experienced:
- Clinical Quality Assurance Professionals
- Clinical Research Associates
- Project Managers
- Personnel involved in IRB assessment and/or selection, Clinical Investigators, Study Coordinators, IRB Members, IRB Professionals, Institutional Officials involved in oversight of clinical research, and GCP-Focused Regulatory Affairs Professionals working with IRBs that review, approve, and oversee clinical investigations regulated by the FDA
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 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#: 0778-0000-12-066-L01-P. Released: 7/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.