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.
The 2024 ISPE International Honor Awards enable the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its
As the pharmaceutical industry continues to evolve at an unprecedented rate, the design and delivery of manufacturing facilities must keep pace with the associated changing
In the fast-paced and ever-evolving world of pharmaceutical manufacturing, companies must respond to and navigate complex challenges to minimize risks and assure their
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...
The landscape of clinical trials has been transformed in a post-pandemic world. The first edition of the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice...