WE-DE-BRC-00: Learning the New Approaches of TG-100 and Beyond

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Abstract

This SAMs Therapy Educational Course will introduce participants to the tools recommended by TG 100 for use in the development of a risk-based Quality Management Program. The Course will start with an Overview of the background and rationale behind the TG 100 initiative, from which its charge was developed. After setting the scene, four 15 minute presentations will introduce the principal components of the soon to be published Report of TG 100. These are Process Mapping, Failure Modes and Effects Analysis, Fault Tree Analysis and the development of a QA/QM risk-based Program. There will be time for two short exercises based on Failure Modes and Effects Analysis and a Discussion before the SAMs questions which will conclude the session.

Learning Objectives:

  • 1.To appreciate the underlying philosophy of the TG 100 initiative.
  • 2.To gain a brief overview of the principal risk-based tools recommended by TG 100.
  • 3.In an informal workshop format, to explore, at an introductory level, the use of risk analysis as proposed by TG 100 as a prelude to the development of a Quality Management Program.

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