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Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool
Session Chair(s)
Janis A Little, MS
Vice President, Global R&D Quality
Allergan Inc, United States
This co-presented workshop will provide an overview of the Transcelerate Clinical Quality Management System Framework tools that are available and also will include a demonstration of the TransCelerate Assessing a Clinical QMS Tool and how an attendee may approach an initial assessment of their organization’s Clinical QMS as to generate a baseline assessment.
Learning Objective : Describe the proposed QMS framework and how it may be used to drive excellence in Clinical Development; Identify considerations and processes that may be used in assessing an organization’s clinical quality management system in alignment with the QMS Concept Paper; Describe key benefits of assessing a clinical QMS within the context of your organization’s quality goals/objectives.
Speaker(s)
Overview of Transcelerate Clinical Quality Management System Framework Tools
Janis A Little, MS
Allergan Inc, United States
Vice President, Global R&D Quality
Assessing the Clinical Quality Management System: An In Depth Look at TransCelerate’s Assessment Tool
Michael Husovich
Amgen Inc., United States
Director, Global R&D Quality