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Session 6 Track 3: Advancing Inspection Readiness Through Data Driven Planning and Continuous Process Improvement
Session Chair(s)
Jamie O'Keefe
Head, Clinical & Regulatory Consulting
Astrix, United States
Joanne Malia, MS, MSc
Director, Development Records Management
Regeneron Pharmaceuticals, United States
Leveraging eTMF data to drive process optimization and Inspection Readiness; Learn how you can optimize your TMF Management processes and eTMF system by analyzing data that you are likely already collecting. In this session we will explore some of the reasons why maintaining an inspection ready TMF is so challenging and will explore ways in which we can achieve better inspection readiness by improving processes and oversight through data and metrics driven approaches. We will focus on operational and findings data analysis, to take the next step and leverage this analysis to drive process improvements.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the principle and challenges of inspection readiness and review new approaches to solving these challenges through data extractions and clinical process modelling
- Identify document types that are most problematic in your organization
- Gain better understanding on TMF metrics and reporting/oversight
Speaker(s)
Driving Inspection Readiness Through eTMF Data
Paul Fenton, MBA
Montrium, Canada
CEO
Analyzing TMF Quality Data to Drive Process Improvement
Michael Agard, MS, RPh
NNIT, United States
Director Clinical Consulting US