Course Description

Process Enhancement through Quality-by-Design

This course is currently at capacity or unavailable for registration, please contact Customer Service at (732)613-4500 or for more information.

Course ID 2783

In-Person Course

Who Should Attend?
This course is especially designed for professionals in the pharmaceutical and biopharma industries. However, the course can easily be applicable to encompass food and chemical processing. Managers, Engineers, Analytical Scientists, Formulators, Purchasing Agents working in these industries will benefit greatly. It is applicable to departments such as Production, Analytical R&D, Quality Assurance, Quality Control, Pharmacy R&D and Purchasing/Budget Office.

Course Description
This two-day intensive, accredited training is focused on the principles, legal underpinnings, tools, and practical applications of Process Analytical Technology (PAT), Quality by Design (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 continuous manufacturing (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.

Course Director
Emil W. Ciurczak, Near-Infrared Consultant to the Life Science Industries

Emil W. Ciurczak, holds advanced degrees in Physical and Analytical Chemistry from Rutgers and Seton Hall Universities and is a consultant in Near-Infrared, specializing in the pharmaceutical industry. He is currently developing instruments and applications for the industry while teaching courses in NIR and PAT/QbD in the US, Europe, Asia and Africa. Since 1970, Mr. Ciurczak has worked at Ciba-Geigy, Sandoz, Cooper Labs (Berlex), Merck and Purdue Pharma. He has consulted and worked for Technicon (Bran+Leubbe), NIRSystems (Metrohm)), Infrared Fiber Systems, Brimrose, and CDI Pharma. He received the 2004 Eastern Analytical Symposium “Achievements in NIR” award.

Mr. Ciurczak has taught (adjunct) at Stevens Tech, College of St. Elizabeth, Hood College, and Mount St. Mary’s College. He is a founding member of the Council for NIRS, is on several USP Expert Committees, and was on the FDA’s Subcommittee for PAT. He is co-editor of the “Handbook of NIR Analysis” (3 editions), co-author of “Pharmaceutical and Medical Applications of NIRS” (2 editions) and has a number of other texts and chapters on NIR in print. He holds twelve patents on NIR equipment and software and has over sixty contributed papers published as well as over 250 oral presentations.

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