Pharmaceutical companies are seeking ways to cut costs and streamline manufacturing processes. Recent FDA, EMA, and ICH Guidances have encouraged the industry to use risk-based methodologies and implement faster and more modern sensors and controls. The leading technique for this modernization is Near-Infrared Spectroscopy (NIRS).
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Emil W. Ciurczak, also know as the NIRPROF, has over 40 years of cGMP pharmaceutical experience and 27 years of near-infrared experience, both in industry and with instrument manufacturers. Emil has taught NIR courses for >25 years, designed and patented hardware and software, written texts, and published extensively in journals. As a member of the FDA's Validation Subcommitte on PAT, Emil has been working on PAT and QbD courses, concepts, and applications since its inception.
Emil and his associates at Doramaxx Consulting can work with your company to integrate NIR into your PAT/QbD programs or help design and implement a PAT/QbD program as well as design programs for anti-counterfeiting. We have added courses for Design of Experiments.
Plus a two-day conference on October 27-8.
- Eastern Analytical Symposium
- November 16, 2010, Somerset, NJ.
Basic NIR for Pharma Short Course. Why not drop by for the week? (Nov. 14-18) I'll be there for 5 days.
- IFPAC 2011; 25th Conference
- January 19-21, Baltimore, MD
Process Analysis epicenter; PAT, QbD, lots of FDA folks. Need to be there
- 62nd PittCon
- March 13-18, Atlanta, GA
Still the largest Analytical conference in the US, plus many great papers and short courses
