The Pistoia Alliance is building a pharmaceutical CMC process ontology based on the ISA88/95 framework to standardize laboratory and plant production process recipes to establish standardized definitions, facilitate digital technology transfers and integration with execution systems to capture structured process data for material lot genealogy tracking, streamlined technology transfers, and advanced process analytics, thereby enhancing efficiency and transparency throughout the pharmaceutical production lifecycle. Having shown value of a semantic approach to CMC process management during the initial PoC phase, we have now continued with the next phase of the work to move beyond the PoC to a usable Ontology. Join us to hear what we are working on and how to get involved.
Agenda
- Introduction
- The project
- The process
- How to join
Speakers
- Birthe Nielsen, Pistoia Alliance
- Nisha Bhudia, GSK
- Zach Dance, Merck
- Shankar Vaidyaraman. Lilly
- Prashant Kumar, ZS
- Sharad Maheshwari, ZS
Registration Form