Pharmaceutical and BioPharmaceutical companies need ways to cut costs while improving quality, streamline manufacturing processes, and combat counterfeiting threats. 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.
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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, universities, and instrument manufacturers. Emil teaches NIR courses, Design of Experiment and PAT/QbD Courses, has designed and patented hardware and software (including hardware and software related to anti-counterfeiting), 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 presenting PAT and QbD courses (in US, Europe, South America, and Asia), concepts, and applications since inception 2002.
Emil and his associates at Doramaxx Consulting can work with your company to integrate NIR or Raman 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.
Meet Emil at these meetings
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
-PAT/QbD Short Course (Dubai, UAE, May 12-13)
Private course
-QbD Workshop (Shanghai, China, June 27-28)For information contact: BMAP Global Co., Ltd., Rm. 2009, Hi Time Plaza, No. 888 N. Sichuan Road, Shanghai, China. website: www.bmapglobal.com
-"Successfully Implementing QbD for Modified Release Products" (Workshop, September 16, 2013, Berlin, Germany) an Informa LS conference, "Modified Released in Oral Drug Delivery; overcoming the practical challenges and regulatory hurdles in modified release drug delivery" 17-18 September, Berlin, Germany
for information call Emma Emberson +44 (0)20 3377 3389; email emma.emberson@informa.com
