E18: How to Develop Validated HPLC Methods: Rational Design with Practical Statistics & Troubleshooting

Two-Day Course 
Dates are TBA; 8:30am – 5:00pm

Dr. Brian A. Bidlingmeyer, Analytical Acumen Inc., Wilmington, DE
Dr. Stanley N. Deming, Statistical Designs, Houston, TX

This two-day course offers practical training for the practicing scientist. Follow a step-by-step approach to develop validated HPLC methods. Learn a systematic approach to methods development that provides sustainable validation by using statistics and statistical process control tools. With emphasis on practicality, the course proposes a straightforward, iterative process to integrate the method development and validation activities. How to carry out routine maintenance to prevent loss of validation, and set diagnostics to recognize behavior that requires troubleshooting will be discussed. Consult with instructors who have years of experience in industry and academe.  Leave with a strategy for developing your own validated methods.

This two-day course is intended for individuals who will be or are developing and/or doing quantitative HPLC analyses. Laboratory managers, supervisors, analysts, chemists, biologists, engineers and technicians who will be or are responsible for the continual use of validated HPLC methods of chemical analysis should attend this course and will all benefit from this course.

1. Method Evolution
     a. Thinking ahead makes the tasks easier
     b. The top four items to be successful
2. Basic Statistical Concepts
     a. Calculations with statistical significance
     b. Parameters of merit
3. Detection Options
     a. Choices and trade-offs
     b. Typical uses and sensitivities
4. Determining Accuracy, Precision and Linearity
     a. Making measurements
     b. Proper calculation of validation parameters
5. Achieving Separations
     a. The chemistry of resolution
     b. Follow the flow chart: a rational strategy for achieving resolution
c. Case study
6. Sample Preparation
     a. Review of techniques
     b. How to improve the analysis
7. Determining LOD, LOQ, MDL
     a. Understanding your limits
     b. A simple, fundamental statistical approach
8. Achieving Method Stability and Robustness
     a. System suitability
     b. System component contributions
9. Optimizing Using Window Diagrams
     a. Finding the tallest trees in the forest
     b. Choosing the best of several optima
10. Using Statistical Quality Control of Separations
     a. An easy graphical method
     b. Achieving sustainable validation
11. Troubleshooting Out-of-Control Systems
     a. Things you often forget to look for
     b. Group discussion of typical issues
12. Putting It All Together
     a. Approaching the steps to validating a method
     b. When steps are necessary and when they’re not
     c. Case Studies

Dr. Brian A. Bidlingmeyer is an accomplished scientist in the field of separation science.  Presently he is affiliated with Analytical Acumen, LLC a technology development company. Brian  as published over 100 technical papers and authored two books, one on practical HPLC and the other on preparative chromatography. He has a wide range of work experience including the pharmaceutical, the industrial chemical and the instrumentation industries. He has worked for Amoco Chemicals as a research chemist, for Waters as Vice President/Technical Director, for Sterling Winthrop Pharmaceuticals as an Assistant Director. He was a co-founder of Cohesive Technologies. Brian was most recently employed by Agilent Technologies where he developed new column technologies and applications. Over the years, Brian has made significant contributions to the practice and understanding of modern HPLC and as a result he has received numerous awards. These include the Heinrich Emmanuel Merck Prize for contributions to analytical chemistry, the International Ion Chromatography Award, the Eastern Analytical Symposium Award in Separation Science, an IR 100 Award for an innovative separation for amino acids (PicoTag Method) and several others. Brian is among the few who have been selected as a Fellow of the American Chemical Society. Presently he is an independent consultant as well as an Associate Editor of J. Chromatographic Science and a past member of the editorial advisory board of LC/GC Magazine.

Dr. Stanley N. Deming is Professor Emeritus at the University of Houston in Houston, TX. He is also the President of Statistical Designs, a firm that offers short courses and consulting in the areas of methods development, process optimization, experimental design and statistical analysis of laboratory data. Stan has taught more than 500 highly acclaimed short courses for the ACS and other organizations. He has co-authored 3 books and approximately 100 papers. Stan has been a member of the editorial boards of Critical Reviews on Analytical Chemistry, the Journal of Chemometrics, and Chemometrics and Intelligent Laboratory Systems.