The TAK x500 series of courses are focused on Facility Operations. The first module, X501 is required to take any of the other three modules. Participants will complete 2 synchronous meetings each for 3 hours, with additional work after the meetings. (Section 5 will have only 1 hour meetings but additional work before meetings. See that section's description for further details.)
TAK X501 Facilities Design and Environmental Monitoring provides an overview of key infrastructure components necessary for biomanufacturing sterile drugs in clean facilities that meet regulatory obligations.
Courses offered from 9a-12p must meet a minimum of 10 registered participants. Courses offered from 5-8p must meet a minimum of 5 registered participants. Courses that do not meet the minimum will not be offered. Individuals signed up for sessions that are cancelled during under enrollment may switch to other sessions.
- Room Classifications
- Takeda BP site drawings
- HVAC/AHU separations
- Differential pressure, pressure cascades, etc.
- HEPA filtration/certification
- Multiproduct controls (bubble airlocks)
- Environmental monitoring equipment and verification
- Disinfectant studies
- Water monitoring