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Effectively Implementing Process Analytical Technology (PAT)

Item Number: SEIR100
List Price: $397.00
Price: $199.00
You Save: $198.00 (50 %)

Conducted by Emil Ciurczak
Author of Spectroscopy's popular
Molecular Spectroscopy Workbench column

Would you like to know more about how you can use PAT (Process Analytical Technology) to make your processes more efficient?

Come learn about this new and exciting way of producing pharmaceutical products!

This audio seminar CD will present the basics of the FDA Guidance, the hardware involved, and putting a PAT Committee together. You will learn how PAT can make your processes run faster and more efficient.

The session will explain how PAT is a new paradigm from cGMP, the many types of instruments and monitors applicable, how new (compliant) software is essential and why the payback is expected to be so large. The pressures of regulations and consumer groups on the pharmaceutical industry and how the product is made will be discussed: how almost any process can be sped up and reworks and failure virtually eliminated.

This audio seminar CD will be conducted by Emil W. Ciurczak. Mr. Ciurczak is a well-known consultant in Near-Infrared and Process Analysis Technology and teaches for the Center for Professional Advancement in the US and Europe. He is the co-author the “Handbook of NIR Analysis” (1st, 2nd Eds.) and Contributing Editor for “Molecular Spectroscopy Workbench” column in Spectroscopy and Contributing Editor for Pharmaceutical Manufacturing.

Specific areas that will be covered include:

  • Origin of the FDA's PAT Guidance
  • The various methodologies employed for PAT monitoring
  • The software used in PAT
  • Some applications currently being performed
  • Questions and answers regarding PAT

By the end of the hour, you should have a better understanding of PAT and how it can improve and optimize your systems and processes. It may even help you enhance and advance your career. A detailed outline and Mr. Ciurczak's qualifications follow below.

Effectively Implementing Process Analytical Technology (PAT)

Part I
The Reasons fort PAT

  • Efficiency of the Pharmaceutical Industry
  • Cost of Producing Product
  • Pressures from Congress and Consumer Groups

Part II
USFDA PAT Guidance

  • What does it say?
  • To whom does it apply?
  • Where can it be used?

Part III
Tools used in PAT

  • Where do we measure?
  • What do we use?
  • Monitors versus Analyzers
  • Some new and not so new methodologies
  1. Near-Infrared
  2. Thermal Effusivity
  3. Acoustics
  4. NIR Chemical Imaging

Part IV
Future of PAT

  • Will it become mandatory?
  • Who will use it and when
  • Development versus existing products
  • Steps to build a PAT team

Emil Ciurczak

Emil W. Ciurczak has advanced degrees in chemistry from Rutgers and Seton Hall Universities and has worked in the pharmaceutical industry since 1970 at companies such as Ciba-Geigy, Sandoz, Berlex, Merck & Co., and Purdue Pharma. He has done method development on numerous types of analytical equipment. Since 1983, he has done most of his research on pharmaceutical applications of NIR and has published over four dozen journal articles and presented over two hundred technical papers.

Emil is a contributing editor for Spectroscopy (Molecular Spectroscopy Workbench) and has written and edited texts such as Handbook of NIR Analysis (1st and 2nd editions), Pharmaceutical and Medical Applications of NIRS, and Molecular Spectroscopy Workbench. He has also contributed numerous chapters to texts on the subject of NIR applications to life sciences. Emil is also on the editorial boards of American Pharmaceutical Review, Journal of NIRS, and the Journal of Process Analytical Chemistry, and Pharmaceutical Manufacturing. He has chaired the NY and Balt-Wash sections of SAS, was one of the founders of the Council for NIRS, and was the 2002 chair for the IDRC.

He has been an adjunct professor since 1979 and teaches short courses (NIR and PAT) for the CfPA (US and Europe) Emil works as a consultant in the field of pharmaceutical NIR and PAT and holds seven patents for NIR-based devices and software. He was an original member of the PAT sub-committee (for Validation) to the FDA Advisory Board and is a member of the PAT Advisory Committee to the USP.