A ISPE é uma organização sem fins lucrativos, focada no desenvolvimento e disseminação do conhecimento e boas práticas de fabricação para profissionais engajados na pesquisa, produção e distribuição de medicamentos de qualidade para o consumo humano.
A ISPE é uma organização sem fins lucrativos, focada no desenvolvimento e disseminação do conhecimento e boas práticas de fabricação para profissionais engajados na pesquisa, produção e distribuição de medicamentos de qualidade para o consumo humano.
On February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event...
On February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event...
On February 8, 2021, the ISPE Emerging Leaders Committee launched ISPE’s first virtual International Hackathon. 51 ISPE Student and Recent Graduates participated in the event...
Objetivos: O objetivo é auxiliar profissionais no Desenvolvimento, Operação e Manutenção de Validação de Planilhas Eletrônicas que estejam envolvidas no processual de pesquisa...
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...
Objetivos: Qualificar profissionais da indústria farmacêutica para entender, de forma didática e aplicada, quais e de que forma ferramentas estatísticas são utilizadas para...
Your professional development is critical to meeting cGMP regulations and can also be the difference between successful operations and regulatory violations. ISPE Training courses are designed to give you the hands-on...
What can you expect from the biggest aseptic event of the year? Interactive discussions, leading authorities, case studies, industry-critical topics, global regulators, networking, unparalleled insights, and more! Don't...
An ISPE Membership gives you the opportunity to be a part of a community of 18,000+ global pharma professionals, working together to advance the solutions that lead to improved patient health. It’s essential that you're...
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.
Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission.
APQ Guide: Corrective Action & Preventive Action (CAPA) System
Published
The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components.
GAMP RDI Good Practice Guide: Data Integrity by Design
Published
This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity.
Women in Pharma® is a place where women and men—especially those new to the industry—can access a network of mentors, role models, and educational resources to support their professional success. The widespread global interest and...