Quality Agreements are a mainstay of the Good Manufacturing Practice (GMP) sphere as defined in ICH Q7 Section 16.12, and in Good Laboratory Practice (GLP) as inferred in 21 CFR Part 58.1 and 58.35. They have become more common in the Good Clinical Practice (GCP) arena of clinical trial operations as risk-based study management becomes firmly established. Quality Agreements delineate the quality expectations of both the sponsor and outsourced provider and are structured in a shared agreement. Web seminar participants will learn the purpose of, factors that are considered in, and explore possible content of Quality Agreements..
- Define the purpose of a Quality Agreement
- Examine the differences between a Quality Agreement and a Contract for Services
- Identify the critical factors that should be addressed in order to have an effective Quality Agreement
- Evaluate and determine who is responsible for developing Quality Agreements
- Determine who is responsible for enforcing Quality Agreements
- Strategies for managing reticence from vendors about Quality Agreements
- Determine when Quality Agreements should be developed and agreed upon
- Explore possible content of Quality Agreements
- Managers/Directors: Clinical Operations, Quality Management, Compliance
- Clinical Quality Assurance Professionals
Celeste M. Gonzalez, RQAP-GCP, C.C.R.P.
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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 +1 781.972.5400 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 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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-19-021-L01-P. Released: 2/19.