Pharmaceutical companies need ways to cut costs while improving quality, streamline manufacturing processes, and combat counterfeiting. Recent FDA, EMA, and ICH Guidances (Q8, 9, 10, and 11) have encouraged the industry to use risk-based methodologies and implement faster and more modern sensors and controls. The leading techniques for this modernization are Near-Infrared (NIR) and Raman Spectroscopy.
.
Emil W. Ciurczak, also know as the NIRPROF, has over 40 years of cGMP pharmaceutical experience and 30 years of near-infrared experience, both with industry and instrument manufacturers. Emil teaches NIR courses, Design of Experiment and PAT/QbD Courses, has designed and patented hardware and software, written texts, and published extensively in refereed journals. Since being a member of the FDA's Validation Subcommittee on the PAT initiative, Emil has been working on PAT and QbD courses, concepts, and applications since inception 2002.
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 also added courses for Risk-Based (ICH Q8) Design of Experiments for small molecules and biotech products.
I'll be at these meetings and courses. Drop me an email and we can find some time to discuss how I might help you.
You can always keep tabs on my writings at:
-Pharmaceutical Manufacturing Magazine and www.pharmamanufacturing.com
-IFPAC ® 2011 (25th International Forum Process Analytical Technology) Jan. 19-21, 2011 Baltimore, Md.
I'll be in the Dublin area the week of February 27, 2012, if anyone in the region is interested
Still the biggest display of lab equipment in the US of A and well worth the trip.
During the first week of May, 2012, I will be in Istanbul, Turkey,giving a 3-day course: (for details see http://www.qualityacademia.com about the spectroscopic tools used in the pharmaceutical industry: NIR, Raman,UV/Vis, NMR, LIF, FT-IR, etc.
