Archive: Implementing Quality Agreements

February 12, 2019 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

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

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.