Emil W. Ciurczak
Doramaxx Consulting Near-Infrared/Raman/PAT/QbD/DoE
Pharmaceutical and BioPharmaceutical companies are searching for ways to reduce costs while improving quality and streamlining manufacturing processes, yet, continuously combating counterfeiting threats. Recent FDA, EMA, and ICH Guidances and Guidelines (Q8, Q9, Q10, and Q11) have encouraged the industry to use quality risk-based (QRM) methodologies 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 ~50 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 (presenting or attending) 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 column (Therapeutic Dose) at www.pharmamanufacturing.com
Some Meetings and Short Courses I'll be attending or giving in 2019
- IFPAC® 2019 - Advancing the Understanding & Control of Manufacturing Processes; March 3-6, 2019 - Bethesda North Marriott, N. Bethesda, Maryland (Washington, D.C.) USA
- PittCon 2019 - March 17 - 21, 2019 - Pennsylvania Convention Center - Philadelphia, Pennsylvania, USA
- CfPA Short Course- April 25-26, 2019 -Short Course: "Process Enhancement through Quality-by-Design" (Instructor) - New Brunswick, NJ. For further information, curriculum, and brochure, visit: https://www.cfpa.com/CourseDescription/CourseDescription/190425NJ2783/2783?utm_source=CD508&utm_campaign=2783 contact Suzanne Berg, Director of Marketing, at email@example.com or 732-238-1600x4579. When calling, mention Discount Code CD508.
- 2nd World Congress on Advances in Analytical and Bio-Analytical Techniques - Date: May 20-21, 2019 - Renaissance London Healthrow Hotel, London, UK - Website Link: https://analytical-bioanalytical.pulsusconference.com/. PULSUS cordially welcomes researchers, academicians, students, and business professionals in the field of Analytical and Bio-analytical Chemistry from around the world to participate in the upcoming Analytical Techniques 2019. The meeting for this year will revolve around the theme “Exploring New Strand in Analytical and Bio-analytical Techniques” highlighting the most cutting-edge findings in the field of Analytical and Bio-analytical Research.
I will be delivering a keynote talk, entitled New Frontiers in Spectroscopy for Pharmaceutical Analysis and presenting a half-day NIR Short course, "Theory and Practice of Near-Infrared Spectroscopy."
- 14th International Conference on Pharmacology and Toxicology - July 18-19, 2019, Zurich, Switzerland The conference emphasizes the theme “Research Advances in Pharmacological Field”. https://www.meetingsint.com/conferences/pharmacology I will be presenting a paper on monitoring chemical and biological process, using Near-Infrared technology. I will also be chairing a session where the technologies used for chemical and physical control of these processes (e.g., particle size control of solids and slurries).
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"