Specification of User Requirements

3 March 2021 - 3 March 2021
Objetivos: Este treinamento abordará conceitos de como elaborar um Requisito de Usuários atendendo às necessidades da Indústria de Ciências da Vida. Através de dois guias que abordam sólidos conceitos de Boas Práticas de Engenharia e Boas Práticas de...

Oral Solids Production Buildings

2 March 2021 - 2 March 2021
O objetivo desse treinamento é auxiliar profissionais no desenvolvimento, planejamento e gestão de projetos de edifícios para produção de sólidos orais. Serão abordados temas como: tipos e etapas de projeto fluxos de processo conceitos de contenção...

Structuring of Calibration Management

1 March 2021 - 1 March 2021
Objetivos: Proporcionar aos participantes o conhecimento necessário para estruturar um Sistema de Gestão da Calibração robusto e confiável, em harmonia com os requisitos regulatórios e assuntos abordados em treinamentos de capacitação de inspetores...

Emerging Leaders & Young Professionals Virtual Career Fair

27 January 2021 - 27 January 2021
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ISPE Good Practice Guide: Equipment Reliability
News & Press Releases

ISPE Publishes ISPE Good Practice Guide: Equipment Reliability

22 January 2021
ISPE announced the release of its latest Guide, ISPE Good Practice Guide: Equipment Reliability . This Guide offers best practices with respect to equipment reliability, addresses specific opportunities for the pharmaceutical industry beyond the...

Assessing Environmental Impact of Biopharmaceutical Manufacturing

18 February 2021 - 18 February 2021
Assessing Environmental Impact of Biopharmaceutical Manufacturing Consistent with the overall industry trend to reduce environmental impact in manufacturing operations, GSK’s Biopharmaceutical Product Development and Supply team have implemented...
Conceptualizing a Streamlined Performance Assessment – The St.Gallen APQ Benchmarking Tool
iSpeak Blog
Conceptualizing a Streamlined Performance Assessment – The St.Gallen APQ Benchmarking Tool

The ISPE APQ Assess, Aspire, Act and Advance Framework will be complemented with an OPEX Benchmarking and ICH Q10 maturity assessment tool specifically developed for use with the APQ program by the University of St.Gallen, Switzerland. Used in conjunction with the APQ self-assessment tools for quality management maturity, the pre- and post- benchmarking activities offer objective evidence of...

Regulatory Requirements & Expectations for Cleaning & Disinfection of Controlled Manufacturing Areas

9 April 2021 - 9 April 2021
Cleaning and disinfection processes are often undervalued. This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas. The pertinent regulations and...

Lessons Learnt from the Discovery of Nitrosamines in Drug Products

25 March 2021 - 25 March 2021
Regulatory observations are clearly demonstrating the safety concerns about unexpected peaks, or unknown components discovered in related substance analyses, which are typically performed using chromatographic techniques. However, they may also...
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