Module 12 Presentations

26/01/2024

SPL – another way to exchange information

Viewed in a style sheet on publicly accessible website maintained by the National Library of Medicine with transfers from FDA. Check out 9000+ labels on DailyMed (nih.gov)

Header SPL Body

The Organisation for Professionals in Regulatory Affairs

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US FDA KASA System – What is it?

K nowledge-aided A ssessment & S tructured A pplication (KASA) It is a data-based platform for structured quality assessments of applications that supports knowledge management. • Captures and manages knowledge during lifecycle • Establishes rules and algorithms for risk assessment, control and communication for product, manufacturing, and facilities • Performs computer-aided analyses • Provides framework for a structured quality assessment A Comprehensive slide presentation can be found here: Slide 1 (casss.org)

The Organisation for Professionals in Regulatory Affairs

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