Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Emil W Ciurczak
OVERVIEW:
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with “commonly used” spectrometers, now in use and more familiar to analysts.
The logic of how various types of NIR equipment is designed and operated, how it obtains and generates spectra, how the software generates results and can control processes.
This webinar will instruct the participants how to
– Evaluate whether or not NIR is the best technology for an application
– What type of instrument would work best (level of sensitivity needed)
– How to write SOPs for operation, calibration, validation, and maintenance of NIR instruments
Why should you Attend: With the industry moving to implement process monitoring (under PAT/QbD) and, with an extended supply chain (thousands of miles and dozens of countries), more and more near-infrared (NIR) spectrometers are being employed.
These can be hand-held, lab-based, or installed in process lines This webinar will explain the manner in which NIR works, the equipment available, and the applications where it may best be used.
– After this webinar, you will be able to evaluate which type of NIR would be best for your application
– How to generate samples for the calibration and validation of NIR instruments
– How to maintain and update NIR equipment and measurement equations
Areas Covered in the Session:
– Brief history of NIRS
– What are the types of hardware available?
– Why are they so different and why does each have different strengths?
– What are the benefits of using NIRS in the warehouse and production?
– Why is a NIR method validated somewhat differently from “common” methods?
– Important applications
– How many parameters can be measured and how quickly?
– Applicable FDA/EMA Guidelines/Guidances for developing a NIR method
– Steps to develop an SOP (NIR Method):
– Prepare or obtain calibration standards
– Develop the Calibration (Chemometric equation)
– Validate the equation
– Maintain the equation
– Update equation (as materials or equipment change)
– Training personnel on NIRS and data handling/troubleshooting
– Writing the revised NDA/ANDA to switch from compendial to NIR method
Who Will Benefit:
– Lab Managers (AR&D, QC)
– Process Engineers
– Technical Managers in General
SPEAKER PROFILE:
Emil W. Ciurczak has been working with NIR for over 35 years. He is the co-editor of the “Handbook of Near-Infrared Analysis” (4th ed in prep) and co-author of “Pharmaceutical and Medical Applications of NIR Spectroscopy” (1st, 2nd editions). He has over 100 refereed publications and over 350 presented papers on the subject and is a Contributing Editor to Pharmaceutical Manufacturing and Contract Pharma magazines (over 450 columns).
He has been teaching NIR/Raman, PAT, QbD, and Design of Experiment for various organizations since 1988 in the US, Asia, South America, and Europe. He has almost 50 years of pharmaceutical experience and has taught various chemistry courses at the college level since 1979. He holds twelve patents for NIR hardware and software.
He won the 2004 EAS “Achievements in NIR” award was a member of the FDA’s subcommittee on PAT in 2002. Emil has worked for Ciba-Geigy, Merck, Sandoz, and Purdue Pharma in addition to working with several NIR instrument manufacturers in his career, and currently consults for Pharma companies and instrument manufacturers.
