Pharmaceutical Professionals Who Can Help
Teaching Companies How to Produce Drugs Faster, Safer and at a Better Cost Get in Touch
Helping Pharmaceutical and Biopharmaceutical Companies
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 PAT 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.
Latest Edition of the Handbook of NIR Analysis Available As is the 2nd Edition of Pharmaceutical and Medical Applications of NIRS
Meet Emil at these Locations
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
Some Meetings and Short Courses
I’ll be attending or giving in 2023
IFPAC 2023, June 3-7, North Bethesda, Maryland
IFPAC continues to set precedence as a forum for insightful discussions bringing you the latest trends and real-life applications in the fields of Quality by Design, Process Analytical Technology, Emerging Technologies, Quality Metrics, Continuous Manufacturing and Process Control applications for the pharmaceutical, biotechnology, generic, chemical, petrochemical, food, and related industries.
IFPAC 2023 Cortona, October 8-11, Cortona Italy
Similar to the meeting in Maryland, but populated with (largely) European atteandees. Smaller venue, all plenary talks.
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”