Description

The TAK x500 series of courses are focused on Facility Operations in biopharmaceutical manufacturing.  The first module, X501 is required to take any of the other three modules.  TAK X504 is the fourth in the Facilities Operations series, and focuses on testing the Process Stream to verify quality. There is one synchronous meeting for three hours, with required work to be completed after the meeting and submitted to the course site within one week. (Section 5 will have only a 1 hour meeting but additional work before meetings.  See that section's description for further details.)

TAK X501 is required to take 502, 503, and 504.

Objectives

Topics Covered:

• 0.1/0.2 micron and Viral filters
• Bioburden/endo analysis throughout the process stream
• Testing strategy