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Thursday, June 28 • 9:00am - 10:15am
#410: Assessing Your Clinical Quality Management System: An In-Depth Look at TransCelerate’s Assessment Tool

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Component Type: Workshop
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Janis A Little, MS


Overview of Transcelerate Clinical Quality Management System Framework Tools
Janis A Little, MS

Assessing the Clinical Quality Management System: An In Depth Look at TransCelerate’s Assessment Tool
Michael Husovich

avatar for Michael Husovich

Michael Husovich

Director, Global R&D Quality, Amgen Inc.
Michael is currently Director of Global R&D Quality Operations at Amgen. Michael is responsible for advancing Amgen's R&D Quality Management System including Business Process Management, Document Management, Issue CAPA Management, Quality Risk Management and driving Operational Excellence... Read More →
avatar for Janis Little

Janis Little

Vice President, Global R&D Quality, Allergan Inc
Janis Little is Vice President, Global R&D Quality at Allergan. In this role she is responsible for oversight of the R&D quality function, setting strategic direction for the organization and ensuring development and implementation of a risk-based audit program, inspection management... Read More →

Thursday June 28, 2018 9:00am - 10:15am EDT
Room 252AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Workshop