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 and 2020
IFPAC 2020 February 23-26, 2020, North Bethesda, Maryland (Washington, D.C.) USA, "Leading the Way in Advanced Manufacturing Science through Innovation, Emerging Technologies & Control." The "Super Bowl" of process analytical chemistry, with heavy accents on pharmaceutical manufacturing, both proprietary and generic.
18th Annual Contracting & Outsourcing Conference& Tabletop Exhibition, September 26-27, 2019 at Hyatt Regency New Brunswick, NJ, located in the heart of New Jersey’s pharmaceutical industry. The two-day conference and one-day exhibition on September 26th provides the perfect venue for easy, informal discussions for manufacturing, packaging, laboratory services and more! The tabletop exhibition will be held one day only on Thursday, September 26th with an additional half day of sessions held on Friday, September 27th. I'll be there doing interviews for Contract Pharma.
Pittcon 2020 Pittsburg Conference & EXPO 01 - 05 March, 2020, Chicago, IL, USA. "The Future of Laboratory Sciences." Still one of the most important meetings to see what's new in hardware and software for analytical chemistry. I will b chairing a session, as usual and will be there for the week.
IFPAC® - Europa Cortona Conference - 2020, October 4 - 8, 2020, Centro Convegni Sant’Agostino, Cortona, Italy. An International meeting on Pharma and Biotech Manufacturing Innovation, Advanced Analytics and Process Control, Informatics, Big Data, Knowledge Management and Global Regulatory Initiatives For the Pharmaceutical, Biotechnology and related Manufacturing Industries. Smaller than US, it is more intimate and worth attending.
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"
Emil W. Ciurczak
Doramaxx Consulting Near-Infrared/Raman/PAT/QbD/DoE