Pharmaceutical Professionals Who Can Help

Teaching Companies How to Produce Drugs Faster, Safer and at a Better Cost

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 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.

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

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 2020

IFPAC Summer Summit with INDUNIV

Marriott Isla Verde Beach Resort in Carolina, Puerto Rico

The conference program is based on a quadrant approach, where each quadrant of the IFPAC Summer Summit conference will have a specific topic and set of deliverables.

Quadrant I: Continuous Manufacturing
Quadrant II: PAT & Analytics
Quadrant III: Implementation of Biologics - Cell Therapies & SUS (Single Use Systems)
Quadrant IV: Data Integrity and Pharma 4.0

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"

Doramaxx Consulting