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Post-market surveillance for manufacturers is covered in Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course. Read More

This self-paced learning course provides comprehensive instruction on the Process Validation and Equipment Qualification in pharmaceutical manufacturing. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically begin the next module within this course. Completing the three modules will provide learners with a holistic view of validation encompassing pre-validation studies, process development, and process evaluation, emphasizing modern approaches that apply principles of QbD, PAT, and ongoing quality risk management (QRM).   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will be able to: Explain the differences between active pharmaceutical ingredients, a bulk drug substance, and drug product Explain the r purpose of equipment qualification and process validation Describe how performance supports product quality by reducing variability      Module 2 - Intermediate Topics – approximately 1.5 hours At the end of this module, you will: Understand WHY, WHAT, and HOW to perform validation Learn the stages of process validation Understand the importance of change control in the context of pharmaceutical quality systems Recognize the important of building in  system safeguards – engineered or procedural   Module 3 - Advanced Topics – approximately 2 hours At the end of this module, you will be able to: Discuss Modern Process Validation and Guidance (FDA and ICH) Understand the importance of pre-validation studies to develop process knowledge Outline the importance of Quality Risk Management and how it applies to process validation (ICH Q09) Identify the importance of validation design and how to reduce variability   Outline a framework for reducing potential product quality and patient risks during commercial manufacturing and throughout the product lifecycle   *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read More

Course Description: This ​five-day ​course ​provides ​the ​skills ​and ​knowledge ​that ​have ​taken ​many ​experienced ​auditors ​decades ​to ​develop. ​During ​the ​course, ​you ​will ​plan ​and ​prepare ​audits ​based ​upon ​case ​studies ​that ​simulate ​both ​supplier ​and ​third-party ​audits ​utilizing ​the ​MDSAP ​audit ​requirements. ​Throughout ​the ​course, ​you ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning, ​preparation ​and ​evaluation ​of ​audit ​evidence. ​You ​will ​also ​practice ​the ​application ​of ​ISO ​13485:2016 ​and ​the ​MDSAP ​requirements. ​ The 5-day event consists of 4 days of different interactive sessions about auditing followed by a 2-hour written virtual examination on the 5th day.  Our course requires that you work together with your tutors for 40 hours before the examination. That means you will have four long 10-hour days together.  To help us understand your needs and focus, there is a mandatory document that are available once full payment is received. These will need to be completed and returned to (jbizien@nsf.org) by the date indicated upon download.   Read More

DESCRIPCIÓN COMPLETA: COVID-19 es una pandemia de proporciones históricas. Ha causado importantes casos de enfermedad y muertes en todo el mundo y ha desafiado a los profesionales de salud pública a implementar las mejores medidas para mitigar o limitar la propagación de COVID-19. La serie de capacitación introductoria: Fundamentos de la respuesta ante una pandemia de COVID-19 de NSF International, tomada en su totalidad o como módulos de aprendizaje independientes, se ha desarrollado para proporcionar un punto de partida para construir y fortalecer su conocimiento fundamental en algunas de las áreas claves críticas para su función de supervisar la respuesta de su organización a COVID-19 o como Coordinador de Prevención de Riesgos de COVID-19: prevención planificación de respuesta y dirección del cambio de cultura. Esta serie de capacitación lo ayudará a comenzar en estas tres áreas claves para comenzar a construir su conocimiento fundamental para implementar medidas para mitigar o limitar la propagación de COVID-19 y beneficiará a numerosas personas dentro de la empresa responsables de cualquier aspecto de estas actividades. Usted recibirá un Certificado de finalización satisfactoria después de aprobar una evaluación de conocimientos para cada módulo. Si completa los tres módulos y aprueba una evaluación completa de conocimientos, recibirá un certificado para la serie de capacitación.   Quien debería participar en este curso Coordinador de Prevención de Riesgo de COVID-19 Prevencionistas de Riesgos y Salud Laboral Inspectores de salud y seguridad Recursos humanos Gerentes de operaciones e instalaciones Personal encargado de supervisar la respuesta ante COVID-19 dentro de cualquier organización Personal dentro de la empresa responsable de cualquier aspecto de estas actividades. Read More

SÉRIE DE TREINAMENTOS COVID-19: Fundamentos da resposta à pandemia A COVID-19 é uma pandemia de proporções históricas. Além de ter sérias implicações para a saúde das pessoas, está impactando significativamente os negócios e desafiando os profissionais de saúde pública a implementar as melhores medidas para mitigar a disseminação do vírus. A NSF International desenvolveu esta série de treinamentos COVID-19 para encarregados de controlar o contágio da COVID-19 dentro de qualquer organização, desde a autarquia à qualquer pessoa responsável por essas atividades dentro da organizção. Descrição do Curso A Série de Treinamentos COVID-19, realizada em sua totalidade ou como módulos independentes de eLearning, foi desenvolvida para fornecer um ponto de partida para construir e fortalecer seu conhecimento básico em algunas das principais áreas críticas para sua função de supervisionar as ações de sua organização ao COVID-19 como autarquía ou operacional: prevenção COVID-19, planejamento de resposta e promoção de mudança de cultura. Esta série de treinamentos irá ajudá-lo a iniciar nessas três áreas principais para desenvolver seu conhecimento básico para implementar medidas para mitigar ou suprimir a disseminação do COVID-19 e irá beneficiar varios indivíduos dentro da empresa responsável por qualquer aspecto dessas atividades. Você receberá um Certificado de Conclusão após passar por uma avaliação de conhecimento para cada módulo. Quem deve participar: • Autarquia da Organização • Técnicos de Saúde e Segurança • Recursos Humanos • Gerentes de operações e instalações • Pessoal encarregado de supervisionar a resposta ao COVID-19 dentro de qualquer organização • Colaborador dentro da empresa responsável por qualquer uma dessas atividades Read More

This self-paced learning course provides comprehensive instruction on Sterile Manufacturing Practices in pharmaceutical manufacturing.   This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Engaging knowledge checks are provided throughout each module, and the course concludes with a final competency assessment. The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically be able to begin the next module.   Module 1 - Introductory Topics – approximately 1.5 hour Provides key information relevant to microorganisms and sources of contamination, particularly in manufacturing areas.  At the end of this module, you will be able to: Explain the basics of microbiology Recognize what constitutes a sterile versus non-sterile product Define Aseptic environment Identify how specific organisms can cause contamination Recognize how Mother Nature is a potential contamination source Identify other potential sources in a manufacturing area   Module 2 - Intermediate Topics – approximately 2 hours Provides common terminology used in sterile manufacturing procedures such as: Clean Room, Unidirectional air, First air, Restricted access barriers (RABS) versus isolators, autoclave cycle, and isolators.  At the end of this module, you will be able to explain: HVAC Requirements Clean Room requirements and clean room preparation Personnel and material flow Primary packing components Sterilization with both heat and radiation Depyrogneation Steam in place (SIP) Terminal Sterilization Sterile Filtration   Module 3 - Advanced Topics – approximately 2 hours Provides information related to the practical application of Sterile Manufacturing Practices.  At the end of this program, you will be able to: Describe routes of administration and associated patients Successfully complete the gowning process Explain the interrelation between materials, people, equipment and environment for aseptic processing Be aware of the critical controls in place Identify specialized filling technologies Providing an overview of lyophilization Explain container-closure integrity (CCI) Perform visual inspection Explain clean room monitoring *Completion times included are approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner. Read More

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