Archive: Implementing Quality Agreements
Jan 25, 2021, 20:23 PM
Course Id :
20067
Barnett Code :
BI13686
Date :
November 22, 2019
Conf Date :
Nov 22, 2019, 08:00 AM
Price :
735.00
Site License Price :
1735.00
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, B.S., CVT, RQAP-GCP, CCRP
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Sort order :
2019112200000000
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Project Manager
- Regulatory Affairs
- Study Site Compliance
- Training
series :
- Clinical Trials & Translational Medicine
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