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
- IFPAC® - 2018 (Conference) "Advancing Manufacturing Science... Emerging Technologies... Modernize Pharmaceutical & BioProcessing Manufacturing and Development.": 11-14 February, 2018, Bethesda North Marriott, North Bethesda, Maryland (Washington, D.C.) U.S.A. The meeting where the FDA and EMA have presentations and a large presence. Cutting-edge presentations by all sizes of Pharma companies, Academia, and Agencies. Small, yet significant exposition, with floor displays of vendors and services. I will be there from Saturday, February 10th through Thursday, February 15th , if only to meet the "movers and shakers" of the industry, meet and chat with all the FDA and EMA personnel in attendance, and see new, cutting edge developments and technologies. http://www.ifpacglobal.org/
- The Pittsburgh Conference and Exposition 2018 - PittCon: 26 February-1 March, 2018, Orlando, Florida, USA. I'll be down in Orlando from Saturday, February 24th through Saturday, March 4th. Presented since 1950, PittCon works in collaboration with Spectroscopy Society of Pittsburgh (SSP) and the Society of Analytical Chemists of Pittsburgh (SACP) to help in the development, research, and future excellence of science education and its implementation for providing best medical assistance. I will be chairing a morning session on Tuesday, Feb. 27th, then exploring the exhibits, and having fun seeing all the latest equipment for the rest of the week. http://pittcon-expo2018.org
- (Short Course): "Theory and Practice of Near Infrared in the Life Science Industries": 20–21 March, 2018, New Brunswick, NJ. Sponsored by the Center for Professional Advancement (CfPA). The two-day course will provide a brief introduction/review of NIRS theory, various types of equipment and where to apply them, an overview of the math involved (Chemometrics), and numerous real-life examples of the versatility of the technology. For more information or to register call (+1) 732-613-4500 or emailCfPA at:email@example.com (Discount Code CD508)
Course Topics Include:
– Choosing the Right Tools
- Theory of NIRS and Instrument Design
– Qualitative and Quantitative Analysis
– PAT Initiative and Guidance
– Application to Nutraceuticals
– Real World Examples
Participants are encouraged to bring their problems for discussion
- (Short Course): Process Enhancement through Quality-by-Design": March 22-23, 2018, New Brunswick, NJ, Sponsored by the Center for Professional Advancement (CfPA). (Course Offering: 180322NJ2783, Course ID 278) This two-day intensive, accredited training is focused on the principles, legal underpinnings, tools, and practical applications of PAT, QbD, and Continuous Manufacturing (CM). The first day will review the FDA, EMA, and ICH documentation that lay the groundwork for using PAT/QbD. It will also cover the concepts of risk, risk assessment, and risk management, which are the underpinning of Design of Experiments. It will also cover the tools needed for a successful PAT/QbD (and CM) program with examples of each technology. Examples of how risk analysis and validation of NIR tablet analyses were performed in an industrial setting.
Day two will offer practical examples of Design of Experiment (solid dosage forms), an overview of Question Based Reviews (QbR), scale-up with PAT and QbD methodologies leading to fully CM. This training will show how PAT may be used as a stand-alone concept, as the heart of QbD, and as the backbone of continuous manufacturing. At every point, time and cost savings, as well as increased quality with reduced risk are emphasized.
This course will encourage attendee participation and will offer opportunities for both group and individual informal discussions with the Course Director (a.k.a, "free consulting"). (Discount Code CD508) (Venue Information: New Brunswick, NJ Area, Hotel Information sent with course confirmation package.)
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"