DIA 2018 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-630-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore multiple ways that quality professionals can take advantage of data generated across their company and turn data into insights to drive quality improvement. Presenters will review how biostatistical analytic tools from risk-based monitoring can be leveraged to improve audit planning and conduct, including a case study to demonstrate the effective use of these tools. The discussion will then turn to leveraging audit data and metrics for risk identification, evaluation, mitigation and effective CAPA. This presentation will draw upon analysis of data from GCP audits conducted globally over three years. Finally, the session will conclude with a presentation on predictive analytics that leveraging a range of information across an R&D organization to yield tangible insights about the risk of quality events in clinical development.

Learning Objectives

Assess the range of data sources, information, and tools that could be leveraged by clinical quality organizations; Discuss different approaches for turning data into insights, from simple metrics to advanced analytics.

Chair

Ann Meeker-O'Connell, MS

Speaker

Augmenting Clinical Research Site Audits with Statistical Analysis Tools
Gloria Miller, RAC

Leveraging Audit Data and Metrics for Risk Identification and Evaluation
Shehnaz Kairas Vakharia, MSc

Industry Perspective
David Donohue, MBA