Wisconsin Chapter: Data Integrity and Quality Culture

RAC Credits
Wednesday, 04 March 2020 (5:30 PM) - Wednesday, 04 March 2020 (8:30 PM) Central Time (US & Canada)
1240 Deming Way
Madison, Wisconsin, USA, 53717-1954

Member: $30
Nonmember: $45

For all FDA-regulated products, data integrity has been at the forefront of agency inspections and frequently is cited for noncompliance on FDA 483 observations and in Warning Letters. Data integrity impacts the entire lifecycle of a product, irrespective of technologies utilized and is a critical aspect of a firm’s quality system. Violations impugn product value, and can jeopardize patient safety and erode public confidence. In addition, it can have a devastating impact on implicated organizations due to the significant resources needed to properly assess consequences and implement controls to ensure any problematic practices are not systemic. In the end, regulatory bodies must trust the data provided by regulated companies.

This presentation will cover topics such as identifying flags in electronic systems (both laboratory and manufacturing), considerations for data integrity and auditing of paper-based systems, recommendations for routine data auditing, and assessing your company culture and its impact on data integrity.

This event, hosted by Accuray, Inc., is brought to you by the RAPS Wisconsin Chapter to encourage knowledge sharing and community development. Dinner will be available for all participants, and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Jennifer Ahearn, director of regulatory compliance, pharmaceutical and medical devices, Engineering Systems Inc. (ESI)