Conteúdo Programático: Parte 1: INTRODUÇÃO À AVALIAÇÃO TOXICOLÓGICA Importância do PDE; Impactos do PDE na Indústria: PDE e o Paciente PDE na Saúde do Colaborador PDE no Desenvolvimento Farmacotécnico PDE na Produção PDE na Qualidade Gerenciando os...
Objetivos: Este treinamento tem como objetivo apresentar o conteúdo do guia de Boas Práticas ISPE “Project Management for the Pharmaceutical Industry”. Além do conteúdo deste guia, serão abordados o guia de gerenciamento de projetos do PMI, o PMBoK...
Com a publicação da RDC 301/2019 (ANVISA), a atualização dos profissionais envolvidos no tema se torna ainda mais prioritária. Através do treinamento de GAMP 5® serão abordados os principais temas, metodologias e ciclo de vida totalmente aderentes...
Assessing Environmental Impact of Biopharmaceutical Manufacturing Consistent with the overall industry trend to reduce environmental impact in manufacturing operations, GSK’s Biopharmaceutical Product Development and Supply team have implemented...
While regulations regarding GMP for APIs clearly define compliance needs, the responsibility for defining necessary GMPs and controls for excipients in a specific medicinal product rests with the Manufacturing Authorization Holders (MAH)...
The presence of endotoxin in sterile pharmaceutical products presents a significant risk to patients. The primary source of endotoxin is pharmaceutical grade water, due to the potential for Gram-negative bacteria to be present. The water source of...
Maintaining and improving GMP compliance of cleanroom manufacturing operations is a mandatory requirement for all pharmaceutical manufacturers. In addition, cost and sustainability of manufacturing operations are an increasing focus, especially given...
Although QRM is not new (cf. CHQ9 - 2005), the regulatory focus on QRM will increase with the arrival of the European Medicines Agency’s Annex 1, which was reviewed by the US Food and Drug Administration, the World Health Organization, and the...
Part 1: EM Trending Requirements Overview on requirements and guidelines on EM data analysis Considerations for EM data analysis using computerized system versus manual systems including speed of analysis, accuracy, volume of data Routine...
