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Tuesday, June 16 • 3:15pm - 3:45pm
#241 SL-CH: A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World

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Component Type: Workshop
Level: Intermediate

Given the current regulatory landscape, we will focus on what each organization should consider using a risk-based approach to be inspection ready, specifically regarding audit trail review and compliance with data integrity.

Learning Objectives

Define GCP for data quality and data integrity specific to audit trail generation and review. Describe the current regulatory framework for organizational data governance, data integrity, audit trail review and inspection readiness within this framework.

Chair

Paula Horowitz

Speakers
avatar for Paula Horowitz

Paula Horowitz

Program Manager, QA, GCP Software Validation, AbbVie
Paula Horowitz is a Quality, Project and Data Management professional with 25+ years experience in Biopharmaceutical, CRO and academic environments. Currently, at AbbVie, Ms. Horowitz is a Program Manager, Software Validation within the QA organization. She provides QA risk-based... Read More →

Tuesday June 16, 2020 3:15pm - 3:45pm EDT
TBD Virtual Event Horsham, PA 19044
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