02, May de 2026
Calibração na Indústria Farmacêutica: de “obrigação regulatória” a vantagem competitiva
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06, 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 […]
Read More02, October de 2024
ABNT NBR 16328:2024 and ISO 17665:2024 norms update
ABNT NBR 16328 and ISO 17665 are essential standards for the sterilization of healthcare products, specifically for measuring temperature, humidity, and pressure in thermal equipment. Both standards were updated in 2024, reflecting advancements […]
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