Course Description

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.

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Learning Objectives

• 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

Who Should Attend

• Managers/Directors: Clinical Operations, Quality Management, Compliance
• Clinical Quality Assurance Professionals

Instructor

Shana Zink, B.S., C.C.R.A.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.