Emil W. Ciurczak
Doramaxx Consulting Near-Infrared/Raman/PAT/QbD/DoE
Pharmaceutical and BioPharmaceutical companies need ways to reduce costs while improving quality, streamlining manufacturing processes, and combating counterfeiting threats. Recent FDA, EMA, and ICH Guidances and Guidelines (Q8, Q9, Q10, and Q11) have encouraged the industry to use risk-based methodologies (QRM) and to implement faster and more modern sensors and controls (PAT/QbD). The leading techniques for this modernization are Near-Infrared Spectroscopy (NIRs) and Raman Spectroscopy.
Emil W. Ciurczak, also known as the NIRPROF, has >45 years of cGMP pharmaceutical experience and >35 years of Near-Infrared Spectroscopy (NIRS) experience with industries, universities, and instrument manufacturers. Emil teaches courses in NIRS, NIR/Raman, Design of Experiment, and PAT/QbD; has designed and patented hardware and software (including hardware and software related to anti-counterfeiting; see "Patents and Publication"); written numerous technical texts and chapters; published extensively in refereed journals, and presented hundreds of technical papers at many conferences, worldwide.
Since being a member of the FDA's Validation Subcommittee for the PAT initiative (2002), Emil has been presenting PAT/QbD, Design of Experiments, and Continuous Manufacturing courses (in US, Europe, South America, and Asia), concepts, and applications since their inception 2002.
Emil and his associates at Doramaxx Consulting can work with your company to integrate NIRS 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 on Risk-Based Management (ICH Q8/Q9) and Design of Experiments for small molecules and biotech products.
I'll be at these meetings and courses below. Drop me an email (or Linkedin message) and we can find some time to discuss how I might help you or just share an adult beverage. In addition, you can always keep tabs on my writings in:
- Contract Pharma Magazine, Check out my monthly column (Analyze This!) at http://www.contractpharma.com/issues/current
- Pharmaceutical Manufacturing Magazine, Check out my monthly column (Therapeutic Dose) at www.pharmamanufacturing.com
- 2-Day Seminar (Short Course) "NIR Spectroscopy in the Life Science Industries (Pharma and BioPharma)" (Course Id: 80571SEM), Philadelphia, PA, June 25-26 [call 1-888-717-2436 for details or check https://www.complianceonline.com/nir-spectroscopy-in-pharma-biopharma-seminar-training-80571SEM-prdsm]]
NOTE: In Case you haven't seen me in person, here is an interview from a few years back at an IFPAC meeting in Baltimore. It is entitled:
"Pharmaceutical Sampling & Testing: Ciurczak Channels Sheldon & Schrodinger"