January Meeting Notice

Tuesday, January 11, 2011

Steven Hansen: Analytical Method Transfers

Steven Hansen

Du Pont Crop Protection
Stine-Haskell Research Center

TONIGHT'S MEETING HAS BEEN CANCELLED DUE TO THE ANTICIPATED SNOWSTORM.

Abstract:

Analytical methods developed for quality control are often transferred from R&D to manufacturing sites. The methods were developed to provide high precision and accuracy. Special precautions need to be taken during the transfer to ensure that the results obtained by the laboratories continue to be of the same high quality. The method development and quality requirements will be described along with the method transfer and evaluation process.
A wide variety of analytical methods are used in crop protection for the development, process development, reaction monitoring, and quality control of intermediates and finished products. Techniques include most often HPLC or GC, but also near infrared (NIR), ion chromatography (IC), and others. There is always a need for precision and accuracy in the methods, but this is particularly true for finished products that are sold to customers. The methods are used to assure that the product meets specifications. The industry is highly regulated and the specifications and analytical methods are part of the regulatory approval process. Validation of the methods to meet regulatory guidelines is challenging, partly due to the various country requirements, but also because the requirements continue to evolve. Beyond the regulatory requirements are the internal requirements for method capability, i.e. the precision of the method or measurement system relative to the specification range for the product. A higher method capability gives us more confidence in the correctness of the analyses.
Transferring a validated and capable method to another laboratory can provide another challenge: how to maintain the same level of accuracy and precision. We have used a process successfully for method transfers of assay and impurity methods inside and outside of DuPont, including 10- to 20-lab international collaborative (CIPAC) studies. Communication and planning are important to a successful transfer. It helps to check whether the laboratory has equivalent equipment, method procedures and method qualification requirements are clearly understood, the method set-up is performed correctly, and experiences and best practices are well communicated. I will describe the test plan that we use and the data evaluation tool that we use for evaluation of the test results and for targeting areas for improvement.

About the Speaker:

I received my PhD. in Organic Chemistry from the University of Iowa under the guidance of Prof. Donald J. Burton. The subject of my thesis was the development of synthetic routes to polyfluorinated organic compounds, building small, commercially-available fluorocarbons into larger, functionalized structures. I began my career with DuPont as a chemist at the Belle Plant, near Charleston, WV, gaining extensive experience in a wide variety of analytical techniques and quality control procedures, including the use of design of experiments for method development. Since 1994, I have been with DuPont Crop Protection R&D, Operations Analytical group, helping to bring new products to market by developing and transferring methods, conducting GLP studies, and authoring reports used in the registration of those products. Our Operations Analytical group works with expert teams in R&D, including organic chemists, chemical engineers, and registration managers. We also work with technical and laboratory experts at manufacturing sites and test facilities, both within DuPont and at contract/alliance partners worldwide.

Details:

Location:	D'ignazio's Towne House
Times:	5:00 PM Executive Committee Meeting 5:45 PM Social "Hour" 6:30 PM Dinner 7:30 PM Presentation
Cost:	$30
Dinner Choices:	Crab Cakes Veal Parmesan & spaghetti Eggplant Parmesan & spaghetti

NOTICE TO STUDENTS AND FACULTY: Full-time students with valid ID may attend dinner meetings at half-price. Faculty members at colleges and universities are urged to bring one or more students to the meeting. If they do, they also can attend at half-price.