14, May de 2026
A Importância da Especificação de Requerimento de Usuário (ERU) na Indústria de Life Science
Sorry, this entry is only available in Português do Brasil.
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02, May de 2026
Calibração na Indústria Farmacêutica: de “obrigação regulatória” a vantagem competitiva
Sorry, this entry is only available in Português do Brasil.
Read More06, November de 2024
AUDIT OF COMPUTERIZED SYSTEMS IN THE PHARMACEUTICAL INDUSTRY: SECURITY AND REGULATORY COMPLIANCE
This article is complemented by: Validação de Sistemas Computadorizados Validação de Sistemas Computadorizados Agile e CSA By Gustavo Soares and Thiago Borin Evaluation based on GAMP 5, 21 CFR Part 11, and the […]
Read More23, October de 2024
AI and ML in the Pharmaceutical Industry
Implementation of AI and ML in the Pharmaceutical Industry: Impact, Standards, and Guidelines By Gustavo Soares Abstract With the advancement of Artificial Intelligence (AI) and Machine Learning (ML) in the pharmaceutical industry, new […]
Read More16, October de 2024
FDA Form 483
The FDA Form 483, issued by the Food and Drug Administration (FDA), is an official document used by the agency to communicate to a company the conditions or practices observed that may violate […]
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