Upcoming Sessions

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Módulo 2: Plano de Resposta diante da COVID-19 O Módulo 2 cobre a definição das funções e responsabilidades dentro de sua organização que contribuem para um plano COVID-19 eficaz, identificação de riscos usando infraestrutura e riscos pessoais com exemplos e desenvolvimento de um plano de resposta para implementar efetivamente os controles em sua instalação. SÉRIE DE TREINAMENTOS COVID-19: Fundamentos da resposta à pandemia vá aqui. Read More

Si esta buscando el Curso “Serie de Capacitación COVID-19: Fundamentos de la Respuesta ante una Pandemia” que contiene los tres módulos y la evaluación final, por favor siga este enlace. Módulo 3: Curso introductorio de COVID-19: Dirigiendo el Cambio Cultural ante COVID-19 El Módulo 3 se centra en el cambio de cultura y ofrece consejos sobre cómo cambiar los comportamientos en una organización y promover la adopción de nuevos hábitos.   Importante: la información proporcionada en estos módulos está destinada únicamente a fines educativos y no reemplaza a las indicaciones regulatorias. La recepción del Certificado de finalización satisfactoria no establece, implica, ni indica de ninguna otra forma que esté certificado, acreditado o registrado. 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

Módulo 3: Mudanças Culturiais em Relação à COVID-19 O Módulo 3 foca na mudança de cultura e oferece orientação sobre como alterar comportamentos em sua organização e promover a aceitação de novos hábitos no contexto da redução do risco de infecção COVID-19. SÉRIE DE TREINAMENTOS COVID-19: Fundamentos da resposta à pandemia vá aqui. Read More

According ​to ​the ​Dietary ​Supplement ​Health ​and ​Education ​Act ​(DSHEA), ​any ​company ​that ​sells ​a ​dietary ​supplement ​containing ​a ​new ​dietary ​ingredient ​must ​submit ​a ​New ​Dietary ​Ingredient ​Notification ​(NDIN) ​to ​the ​FDA. ​In ​this ​course ​we ​will ​provide ​guidance ​on ​how ​to ​determine ​when ​an ​NDIN ​is ​required, ​what ​kind ​of ​information ​you ​will ​need ​to ​include ​in ​an ​NDIN, ​and ​common ​pitfalls. ​The ​course ​is ​directed ​toward ​dietary ​supplement ​and ​food ​ingredient ​manufacturers ​and ​suppliers ​who ​are ​interested ​in ​understanding ​the ​basic ​requirements ​for ​NDINs ​so ​they ​can ​better ​communicate ​with ​regulators ​and ​specialists. Specific topics will include: • How to determine whether you need to submit an NDIN to the FDA • How to decide what kind of testing is required for an NDIN • How to establish safety under the conditions of intended use • How to compile the necessary documentation for a successful FCN • How to avoid common pitfalls associated with preparing an NDIN Instructor: Brad Lampe Please note a PDF of the recording will not be available. You will have access to the recoding for 15 days once you complete your registration. Certificate of participation are not issued for recorded courses​. Read More

Dietary Supplement. Join us for a comprehensive virtual training, designed to build consumer and retailer trust in verified label claims by earning the sought-after “butterfly” logo for your products and ingredients. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will: Learn how to help products stand out in the category with this collaborative 2-hour workshop for Non-GMO Project Verification, focusing on: Defining risk levels Classifying ingredients Identifying specific requirements for common dietary supplement ingredients Facility level compliance requirements Work through common sourcing and ingredient challenges with hands on exercises and case studies Make sense of complex regulations so they can be applied to your organization’s formulations and ingredients Become an in-house expert at Non-GMO Project definitions, standards and requirements Instructor: Marci Burton Note: A PDF of the presentation will not be distributed for this recording. You'll have access to the recording for 15 days once you complete your registration. Certificate of participation are not issued for recorded courses​. Read More

This self-paced digital learning course provides comprehensive instruction on Pharmaceutical Microbiology in pharmaceutical manufacturing.   The program is presented in three modules: - approximate course completion time = *5 hours. Once you finish the first module, you will automatically begin the next module within this course.   Module 1 - Introductory Topics – approximately 1 hour At the end of this module, you will: Explain Microbiological problems in the context of pharmaceutical manufacturing, including how to identify problems Learn the meaning of Microorganisms in their significance Understand HOW microorganisms grow and WHY it matters   ​Module 2 - Intermediate Topics – approximately 2.5 hours      At the end of this module, you will be able to: Review how microorganisms are counted and explain the rapid microbiological methods Outline the Identification of Microorganisms and explain pharmaceutical water systems Review Pyrogens and pyrogen testing Understand microbiological evaluations of raw materials Understand microbiological contamination and spoilage Learn the principles of preservation in the pharmaceutical context Understand Antibiotics and how to assess antimicrobial activity Outline and understand the importance of good disinfection practices   Module 3 - Advanced Topics – approximately 1.5 hours      At the end of this module, you will be able to: Review sterilization principles and methods Explain bio validation of sterilization Describe sterility testing in the pharmaceutical environment Discover Microbiological validation of cleanrooms Review Microbiological Environmental monitoring methods Learn how to perform a microbiological risk assessment *The course is self-paced so completion times are approximate, based on the amount of content in each section. Read More

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