El Affiliate en México de la Sociedad Internacional de Ingeniería Farmacéutica (ISPE) es una asociación sin fines de lucro que sirve a sus miembros liderando el avance científico, técnico y regulatorio a lo largo de todo el ciclo de vida farmacéutico. Como una extensión local de ISPE México Affiliate busca ser líder nacional de la industria en la conexión del conocimiento farmacéutico para brindar innovación en la fabricación y la cadena de suministro, excelencia operativa y conocimientos regulatorios para mejorar los esfuerzos de la industria para desarrollar, fabricar y entregar de manera confiable medicamentos de calidad a los pacientes.
Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project...
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)...
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the second edition of the Guide, provide examples of how these concepts...
Discover why the 2025 ISPE Annual Meeting & Expo is a can't-miss event. Find opportunities to connect with global industry leaders, participate in exclusive events, and elevate your career through unparalleled networking...
We. A simple word...yet it holds the power of thousands of minds, hands, and hearts working together across borders and industries. WE are the collective strength of engineers, scientists, researchers, regulators, and...