Ana Fernández

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Laboratorio De Diagnósticos Y Alimentación S.L. 2008 (LABDIAL)
Ana Fernández Domínguez is a pharmaceutical quality and compliance professional at Labdial, with extensive experience in GMP operations, regulatory inspections, and global quality systems. She has supported manufacturing and quality organizations across international markets, focusing on investigation excellence, audit readiness, and continuous improvement within regulated environments.

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iSpeak Blog
Integrating Artificial Intelligence into Inspection Readiness and Regulatory Response Development: A Technical Perspective and Case Study

Regulatory inspections by the US Food and Drug Administration (US FDA) and other global authorities require pharmaceutical manufacturers to demonstrate sustained compliance with 21 CFR Parts 210/211, ICH Q7, EU GMP Annex 1, and related regulatory frameworks. Traditional inspection readiness models are reactive, labor-intensive, and dependent on significant manual documentation review and...