ISPE Italy Affiliate was founded in Milan in 1992. Currently counts more than 500 members from various sectors of Life Science: manufacturing, engineering e automation, quality assurance, laboratory, logistics, IT, validation, academia and regulatory authorities.
ISPE Italy Affiliate was founded in Milan in 1992. Currently counts more than 500 members from various sectors of Life Science: manufacturing, engineering e automation, quality assurance, laboratory, logistics, IT, validation, academia and regulatory authorities.
ISPE’s Pharma 4.0™ Baseline Guide authoring team received the prestigious Committee of the Year Award, as part of the 2024 ISPE International Honor Awards which were presented
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like antibody-drug conjugates (ADCs) and radiopharmaceuticals driving the
On 16 October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA, Emer Cooke, European Medicines Agency (EMA) Executive Director and chair of the International
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems...
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management)...
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm...
We. A simple word...yet it holds the power of thousands of minds, hands, and hearts working together across borders and industries. WE are the collective strength of engineers, scientists, researchers, regulators, and...
As the pharmaceutical and biotech industry forges new paths and breaks new grounds, ISPE is here to support you on your journey to Shape the Future of Pharma™. Join ISPE today and leverage the member-exclusive knowledge...
Internally, this project has been recognized for superior performance with the 2022 Global Lilly IT Award for the project team’s new material tracking system, and the project team was awarded the Lilly Global Safety...
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT) in bioprocessing for monoclonal antibody (mAb) production. It aims to inform sustainable practices within the...