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Short Course

Course Information
Course Title: How to Develop Validated HPLC Methods: Rational Design with Practical Statistics and Troubleshooting
Categories: 1 - Liquid Chromatography
2 - Pharmaceutical Sciences
3 - Quality/Regulatory/Compliance
4 - Statistics
5 - Validation
Instructor(s): Brian Bidlingmeyer, Stan Deming Course Number: 109
Affiliation: Analytical Acumen LLC
Course Date: 03/04/2017 - Saturday Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/05/2017 - Sunday    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $1100 ($1500 after 2/18/17) Textbook Fee:

Course Description
This course offers practical training for the practicing scientist. This course takes the participant step-by-step through the concepts, techniques and tools necessary to develop validated HPLC methods. Learn a rapid, systematic approach to HPLC methods development that provides sustainable validation by using statistical process control (SPC) tools. Rather than developing the HPLC method and then validating it, this course proposes following a streamlined, iterative process to integrate the method development and validation activities. The approach is effective, efficient and productive. The emphasis is on practical issues associated with developing validated HPLC methods. Case studies illustrate specific problems and how to approach them, how to carry out routine maintenance to prevent loss of validation, and how to set diagnostics to recognize behavior that requires troubleshooting. Discuss your specific method development/validation problems with instructors who have more than 60 years of combined experience in industry and academe. You will leave with a strategy for developing your own validated HPLC methods.

Target Audience
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.

Course Outline
TOPICS
1. Method Evolution
2. Basic Statistical Concepts
3. Detection Options
4. Determining Accuracy, Precision and Linearity
5. Achieving Separations
6. Sample Preparation
7. Determining LOD, LOQ, MDL
8. Achieving Method Stability and Robustness
9. Optimizing Using Window Diagrams
10. Using Statistical Quality Control of Separations
11. Troubleshooting Out-of-control Systems
12. Putting It All Together

Course Instructor's Biography
Dr. Brian A. Bidlingmeyer is an accomplished scientist in the field of separation science and has published over 100 technical papers and authored two books, one on practical HPLC and the other on preparative chromatography. Brian 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 and was employed by Agilent Technologies where he developed new column technologies and applications. Brian has made significant contributions to the practice and understanding of modern HPLC. As a result he has received numerous awards including 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 an editorial advisory board member of LC/GC.