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TU2-20: Quality Risk Assessment in Cellular Therapy Laboratory


Oct 22, 2019 9:00am ‐ Oct 22, 2019 10:30am

Description

Quality Risk Assessment in Cellular Therapy Laboratory 

Critical parameters identified to be a risk to the cellular therapy product should be identified, recorded, monitored and controlled. This educational session will provide examples of metrics and data sources and methodologies to evaluate risk and create a risk assessment matrix that can be used in CTP manufacturing. Identified high-risk situation should be followed with a root cause analysis (RCA) and Risk Reduction Strategies (RSS). The session will provide examples of how to be proactive, anticipate the risk, and not wait for an error occurrence to perform RCA and Corrective and preventive actions (CAPA). We will also discuss how to reassess risk and search for new RSS and implement quality improvement process.

Learning Objectives:

  • Develop a quality risk assessment plan for your laboratory.
  • Select metrics, data sources, and methodologies for the risk assessment matrix.
  • Identify the high-risk situation and perform a root cause analysis (RCA).

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