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
Engineers, Analytical Chemists, Statisticians, Chemometricians
Why should you Attend: 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.
Areas Covered in the Session:
Raw Material Qualification (as it arrives in warehouse)
Blending Uniformity Monitoring
Granulation End-point Determination
Drying End Point Determination
Tablet Compression Monitoring and Analysis
Coating End-Point Determination
Packaging (correct fills, clinical trials)
- Production Managers
- Analytical and QC Managers
- Quality Assurance Personnel
- Purchasing Personnel
- Formulators and Development Personnel
• Production Managers
• Analytical and QC Managers
• Quality Assurance Personnel
• Purchasing Personnel
• Formulators and Development Personnel