PAT and Continuous Manufacturing (Fremont, CA)

PAT and Continuous Manufacturing

We will briefly discuss how to go from minimum sampling sending them to a lab and waiting for results to real-time monitoring taking huge numbers of readings and how to understand and apply these data to control and improve new and existing products.Also discuss will be how to build the PAT CM team and set goals budgets and make the change-overs smoothly and efficiently.Requirements for PAT CM equipment Speed Precision ease of use installation calibration validation Types of Equipment Near-Infrared Raman TeraHertz (for biopharma) Ultra-fast LC Personnel needed Engineers Analytical Chemists Statisticians Chemometricians With mounting economic and legislative pressures on the Pharma Biopharma industries it is understandable that manufacturers are beginning to move to PAT and QbD programs to simultaneously improve their products and allow them to make them more economically.However the typical production facility seldom has the knowledge or the tools to perform in-process testing and control.There is often no awareness of the personnel and more importantly the tools needed need to be identified purchased installed and properly used.This course will show the tools used in PAT QbD and CM what they do and see and what they bring to the effort. The software needed will also be examined and some suggestions made.