This
application-based web seminar covers advanced concepts and challenges
encountered in the application of Good Clinical Practice (GCP). During this
highly interactive course, participants will review and discuss cases that
include GCP challenges in topic areas such as IRB/IEC approval, informed
consent, drug accountability and reconciliation, SUSAR submissions,
communications with ethics committees and health authorities, as well as the
management of investigational product. Cases are based on actual industry
examples, and participants are expected to solve cases by applying Root Cause
Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which
are briefly reviewed.
- Apply your understanding of the GCP standards
most critical to core clinical research job functions
- Explain the role of Quality Systems
in the GCP environment
- Apply GCP through critical thinking
in the context of real-world clinical research scenarios and simulations
- Explain the concepts of RCA and CAPA
to improve site and sponsor performance and compliance
- Clinical Quality Assurance Professionals
- Clinical Research Associates
- Project Managers
- Investigators
- Study Coordinators
- GCP-focused Regulatory Affairs
Professionals
- Clinical Operations Professionals
Janet
Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
Click here for complete trainer
biographies
$835
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 3 hours (0.3
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#: 0778-0000-20-026-L01-P. Released: 3/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.