Hands-On Aseptic Processing & Annex 1 & ATMP Manufacturing Training
To meet the challenges of the new Annex 1 guidance while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 4-day interactive training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. This training provides hands-on opportunities to interact with equipment in a facility built for training pharmaceutical industry workers. During the training sessions, attendees will have the opportunity to conduct aseptic processing steps as well as ATMP manufacturing exercises…
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Biopharmaceuticals: Webinar C> e ATMP
Biopharmaceuticals: Webinar de treinamento em C&GT e ATMP Visão geral Este webinar é uma gravação do novo curso de instrutor que é um curso de nível avançado sobre therapies C e Gene T (C&GT) e Medicamentos de Terapia Avançada (ATMP). O curso também fornece umavisão geral dos componentes mais comuns e estabelecidos que são aproveitados em produtos C&GT (por exemplo, plasmídeos, mRNA, nanopartículas lipídicas, vetores virais), cobrindo terminologia, processos de fabricação e subsequente caracterização analítica de os componentes fabricados e os produtos terapêuticos. As plataformas de células T…
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Produtos Biofarmacêuticos: Aspectos CMC
Modo de Entrega: Webinar Produtos Biofarmacêuticos: Webinar de Treinamento sobre Aspectos CMC Visão geral Este webinar é uma gravação do novo curso de instrutor, que é um curso de nível avançado sobre aspectos de Química, Fabricação e Controle (CMC) do desenvolvimento biofarmacêutico. O objetivo deste curso é fornecer uma compreensão avançada dos aspectos CMC de biofármacos desde o desenvolvimento até a comercialização. O que você vai aprender Visão geral do desenvolvimento biofarmacêutico Qualidade por Design (Quality by Design – QbD) Linhagem Celular e Desenvolvimento a Montante (Upstream)…
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GMP Fundamentals: Production & Process Controls
This course offers an overview of Good Manufacturing Practices (GMP) for medical product production and process control. You will learn about GMP compliance, product design and development, process validation, control systems, and quality control procedures. Regulatory requirements, including FDA and international standards, will be covered. Upon completion, you will understand the fundamental principles and practices of GMP in medical product production. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to…
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GMP Fundamentals: Control of Excipients, Components and Drug Product Containers/Closures
In this course, you will learn about the fundamentals and importance of GMP control in the pharmaceutical industry. Good Manufacturing Practices (GMP), is critical for ensuring the quality, safety, and efficacy of pharmaceutical products. This includes controlling excipients, components, and drug product containers/closures to meet specific standards and requirements, reducing the risk of contamination, degradation, or incorrect formulation. You will gain a deeper understanding of the role of GMP control in maintaining the integrity of the supply chain, and how following GMP guidelines helps…
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