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
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)
Who Will Benefit
- Production Managers
- Analytical and QC Managers
- Quality Assurance Personnel
- Purchasing Personnel
- Formulators and Development Personnel
Emil W. Ciurczak has been working with NIR for over 35 years. He is the co-editor of the "Handbook of Near-Infrared Analysis" (4th ed in prep) and co-author of "Pharmaceutical and Medical Applications of NIR Spectroscopy" (1st, 2nd editions). He has over 100 refereed publications and over 350 presented papers on the subject and is a Contributing Editor to Pharmaceutical Manufacturing and Contract Pharma magazines (over 450 columns).
He has been teaching NIR/Raman, PAT, QbD, and Design of Experiment for various organizations since 1988 in the US, Asia, South America, and Europe. He has almost 50 years of pharmaceutical experience and has taught various chemistry courses at the college level since 1979. He holds twelve patents for NIR hardware and software.
He won the 2004 EAS "Achievements in NIR" award was a member of the FDA's subcommittee on PAT in 2002. Emil has worked for Ciba-Geigy, Merck, Sandoz, and Purdue Pharma in addition to working with several NIR instrument manufacturers in his career, and currently consults for Pharma companies and instrument manufacturers.