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Monday, September 27 • 8:30am - 12:00pm
WORKSHOP A: Quality Tolerance Limits

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Demonstrate the Steps for Defining and Implementing Appropriate Quality Tolerance Limits (QTLs) Through Case Study Examples and Hands-On Learning

Review ICH E6 R2 requirements for quality management, inclusive of risk management
  • Define critical data and processes; what matters most to GCP
  • Differentiate systemic versus clinical trial level risks
  • Establish risk management fundamentals by identifying, evaluating and controlling risks
  • Understanding failure mode effects analysis
Deep Dive into Quality Tolerance Limits
  • Define QTLs, the underlying components, and understand their purpose
  • Differentiate QTLs from Key Risk Indicators (KRIs) and Risk-Based Monitoring (RBM)
  • Evaluate the requirements driving the development of QTLs
  • Understand how QTLs fit into an overarching risk management process
QTLs in Action
  • Learn about a QTL implementation journey
  • Discuss how to monitor QTLs
  • Practice developing QTLs in an interactive session
  • Outline the reporting of QTLS

Speakers
avatar for Jonathan Rowe

Jonathan Rowe

Head of R&D Quality Risk Management, ZS
Jonathan Rowe has 25 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Head of R&D Quality and Risk Management at ZS Associates. In this... Read More →


Monday September 27, 2021 8:30am - 12:00pm EDT