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.
Click here for complete trainer
biographies
$735
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.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com
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.
