Pharmaceutical companies are seeking ways to cut costs and streamline manufacturing processes. Recent FDA, EMEA, 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.
Emil W. Ciurczak, also know as the NIRPROF, has almost 40 years of cGMP pharmaceutical experience and over 25 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 memeber 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 various professional associates at Doramaxx Consulting can work with your company to integrate NIR into your PAT/QbD programs or even help design and implement a PAT/QbD program as well as design programs for anti-counterfeiting. With his extensive experience, Emil has a number of experts at Doramaxx that he can call upon for special projects.
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
- PTi Short Course.
- February 22-23, 2010. London, England.
-Giving Short Course on PAT/QbD in Pharma and BioPharma; history, applications, design of experiment, tools and regulations used.
- PittCon 2010
- February 27-March 4, 2010, Orlando, Florida
- Chairing a session on Spectroscopy in Pharma, interviewing people for Pharma Manufacturing magazine.
-EuPAT: 4th pan-European PAT Science Conference.
-May 5-6, 2010, Kuopio, Finland.
- Presenting two sessions in U of Kuopio: "CTQ Aspects of a Bioprocess" and "Instrumentation Used for PAT in Biopreduction"
- Giving a talk on "NIR PAT-QbD Applications in Biotechnology"
- 6th International BioProcess International
- May 21, 2010. Vienna, Austria.
- presenting a day long workshop on "Design of Experiments for Biotech PAT/QbD" (post conference)
- USP QbD Workshop
- June 15-16, 2010, Sao Paulo, Brazil.
