La FDA está ampliando las inspecciones no anunciadas en emplazamientos internacionales. Descubre cómo los fabricantes pueden mantenerse preparados para inspecciones mediante sistemas resilientes, procesos validados y equipos capacitados.
Read moreFDA is expanding unannounced inspections at foreign sites. Learn how manufacturers can stay inspection ready through resilient systems, validated processes, and confident people.
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Los hallazgos críticos en auditorías GMP requieren una actuación rápida y eficaz. Aprende a identificar señales de alerta, contener los problemas y reforzar tus sistemas de calidad.
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Critical findings in GMP audits demand fast, effective action. Learn how to identify red flags, contain issues, and strengthen your quality systems.
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Outsourcing QA can reduce costs and boost quality, but also brings risks. Learn how to choose the right partner and manage outsourced QA effectively.
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Es obvio que la calidad del producto y la seguridad del paciente son una prioridad máxima en la industria farmacéutica. La metodología de calidad por diseño se utiliza para incorporar la calidad a los procesos de producción. Mediante una comprensión y un conocimiento exhaustivos de los productos ...
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Learn more about the Cost of Goods aspect of cell and gene therapies: what is this cost comprised of and how can you reduce it?
Read moreIt's obvious that product quality and patient safety are a top priority in the pharmaceutical industry. The quality by design methodology is used to build quality into production processes.
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In this FAQ you will learn: What is the definition of ATMP? What makes ATMPs different from other medicines? When is a medicine an ATMP? And much more.
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