!
Developing Validated HPLC/UHPLC Methods
Who Should Attend
Laboratory managers, supervisors, analysts, chemists, biologists, engineers and technicians who are responsible for the continual use of validated high performance liquid chromatographic (HPLC) methods of chemical analysis. Those working in R&D, manufacturing, QA/QC, methods development, process development, product testing, pharmaceuticals, biotechnology, organic chemicals, petrochemicals, environmental chemistry, foods, flavors, fragrances, pesticides, testing services laboratories, and occupational health and safety testing will benefit.
The course is aimed at both beginning and experienced workers. The course assumes some familiarity with chromatography, but no previous knowledge of statistics.
Key Topics You Will Learn About
* How to interpret FDA, ICH, and other guidelines for method validation
* How to implement a systematic approach to HPLC method development
* How to use statistics to demonstrate validity
* How to assure continual validation of HPLC methods by building in ruggedness, and by monitoring with statistical process control tools
* How to achieve effectiveness, efficiency, productivity, and reduced costs
* How to carry out routine maintenance and component testing practices that will prevent loss of validation
* How to set diagnostics to recognize behavior that requires troubleshooting
* How to learn from case studies using practical examples
How You Will Benefit From This Course
* You will develop a confident, positive attitude to method development and method validation
* You will leave with a firm strategy for developing your own continually Developing Validated HPLC/UHPLC Methods
* You will learn how to develop rugged HPLC methods in a timely, cost effective manner
* You will solve real HPLC method development and troubleshooting problems using tools presented in the course
* You will understand trade-offs and choices for determining validation parameters
* You will learn where statistics intersect practice for successful validation
* You will understand systematic troubleshooting of HPLC methods in a cost effective manner
* You will learn how to anticipate method validation and quality assurance when developing HPLC methods
* You will learn how to select the best techniques/components at the beginning
* You will understand how HPLC components work and contribute to the method
* You will learn how to detect and correct problems before the method becomes invalid
* You will discuss your specific method development/validation problems with instructors who have more than 60 years of combined experience in industry and academe
Day 1
* Introduction
* Overview of method evolution
* FDA and ICH guidelines
* Development and validation
* Unit operations in chromatography
* Basic statistical concepts
* Outliers
* Specificity: sample preparation
* Specificity: separations
* Specificity: detectors
Day 2
* Linearity
* Accuracy
* Precision
* Limits of detection (LOD) and quantification (LOQ)
* Minimum detectable amount (MDA)
* Sample stability and method robustness
* Window diagrams
* System suitability
* Statistical process control for HPLC
* Sustainable validation
* Troubleshooting out-of-control systems
* Case studies
* Conclusion of course
Copyright © 2018 by Statistical Designs. All rights reserved.
Statistical Designs, 6208 Llano Libre Way, El Paso, TX 79912-2630
281-841-3992
History
|  | 23. | Eastern Analytical Symposium, Plainsboro, NJ, 13-14 November 2018 |
| --- | --- | --- |
|  | 22. | Pittsburgh Conference, Orlando, FL, 24-25 February 2018 |
|  | 21. | Eastern Analytical Symposium, Plainsboro, NJ, 14-15 November 2017 |
|  | 20. | Pittsburgh Conference, Chicago, IL, 4-5 March 2017 |
|  | 19. | Eastern Analytical Symposium, Somerset, NJ, 15-16 November 2016 |
|  | 18. | Pittsburgh Conference, Atlanta, GA, 9-10 March 2016 |
|  | 17. | Eastern Analytical Symposium, Somerset, NJ, 17-18 November 2015 |
|  | 16. | United States Pharmacopeial Convention, Washington, DC, 5-6 August 2015 |
|  | 15. | Eastern Analytical Symposium, Somerset, NJ, 18-19 November 2014 |
| \* | 14. | American Chemical Society Regional Offering, Philadelphia, PA, 28-29 April 2014 |
|  | 13. | Eastern Analytical Symposium, Somerset, NJ, 17-18 November 2013 |
| \* | 12. | American Chemical Society Regional Offering, Philadelphia, PA, 13-14 August 2013 |
|  | 11. | Eastern Analytical Symposium, Somerset, NJ, 12-13 November 2012 |
| \* | 10. | American Chemical Society Regional Offering, Needham, MA, 2-3 May 2012 |
| \* | 9. | American Chemical Society Regional Offering, Houston, TX, 8-9 December 2011 |
|  | 8. | Eastern Analytical Symposium, Somerset, NJ, 14-15 November 2011 |
|  | 7. | Eastern Analytical Symposium, Somerset, NJ, 17-18 November 2010 |
|  | 6. | Eastern Analytical Symposium, Somerset, NJ, 16-17 November 2009 |
|  | 5. | Eastern Analytical Symposium, Somerset, NJ, 17-18 November 2008 |
|  | 4. | Eastern Analytical Symposium, Somerset, NJ, 12-13 November 2007 |
|  | 3. | Eastern Analytical Symposium, Somerset, NJ, 13-14 November 2006 |
| \* | 2. | American Chemical Society Regional Offering, Woodbridge, NJ, 7-9 August 2006 |
|  | 1. | Eastern Analytical Symposium, Somerset, NJ, 14-15 November 2005 |
|  |  | --------------------------------------------- |
|  | \* | Sponsored by the Education Division, American Chemical Society |