Webinar: Clean Air Systems: Indoor Air & COVID-19

11 February 2021 - 11 February 2021
Clean Air Systems Indoor Air & COVID-19 This round table discussion will explore available Indoor Air Quality (IAQ) technologies aimed at indoor environmental protection from Infectious Aerosols IN THIS WEBINAR YOU WILL LEARN: How buildings affect...
Good Practice Guides

Good Practice Guide: Maintenance 2nd Edition

Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support.
It’s a New Year - Make Accountability a Resolution!
iSpeak Blog
It’s a New Year - Make Accountability a Resolution!

What is accountability? By definition, “it is taking or being assigned responsibilities for something that you have done or something that you are supposed to do.” We can take this far beyond that. Accountability means doing what we say we will do, always, on time and to the best of our ability. It means setting goals and achieving them. It means consideration of others, saying yes to things...

Global Aseptic Leaders
News & Press Releases

ISPE Gathers Global Aseptic Leaders to Discuss Trends, Innovations, & COVID-19 Impact

28 January 2021
ISPE announced its 2021 ISPE Aseptic Conference , taking place virtually on 15–17 March 2021. Now in its 30th year, this signature event has established itself as the pharmaceutical industry's leading source on advancing aseptic and barrier...

Validation of Electronic Spreadsheets

24 March 2021 - 24 March 2021
Objetivos: O objetivo é auxiliar profissionais no Desenvolvimento, Operação e Manutenção de Validação de Planilhas Eletrônicas que estejam envolvidas no processual de pesquisa, desenvolvimento, manufatura, controle da qualidade, importação...

Technical Online Training on Risk Analysis - Applied use of the FMEA Tool

22 March 2021 - 22 March 2021
Objetivo: Situar os participantes sobre a Análise de riscos e o uso dos conceitos da ferramenta FMEA (Failure Mode and Effect Analysis), bem como as principais aplicações junto ao segmento de Life Science (Ciências da vida). Abordagem: O treinamento...

Statistics for Process Validation

17 March 2021 - 17 March 2021
Objetivos: Qualificar profissionais da indústria farmacêutica para entender, de forma didática e aplicada, quais e de que forma ferramentas estatísticas são utilizadas para comprovar a adequabilidade da qualificação de performance de processos...

Process Validation Training with an emphasis on Drug Development.

15 March 2021 - 16 March 2021
O treinamento contemplará as 3 fases de validação (1 desenvolvimento, 2 qualificação do processo e 3 CPV), entretanto a ênfase será na fase 1. Saiba Mais

Managing Risks & Understanding the Impact & Application of the PDE

9 March 2021 - 10 March 2021
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...

Project Qualification

8 March 2021 - 8 March 2021
Objetivos: Aplicando os conceitos atuais de BPE e BPF e as regulamentações vigentes treinar/orientar os participantes a qualificar um projeto de engenharia, equipamentos e sistemas voltados para as indústrias de ciências da vida. Através de um guia...
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