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"Helping People Learn Compliance and Science" SM

 

High Performance Liquid Chromatography

(HPLC) Method Development:

A Practical Course

 

ABOUT THE COURSE

"High Performance Liquid Chromatography (HPLC) Method Development:  A Practical Course"  is a one day course designed to review the process by which HPLC methods are developed and evaluated for suitability of use as test methods, and as precursor to validation in a CGMP environment.  The course highlights the steps which you will have to undertake in order to efficiently and effectively develop a method. The steps taught in the course are based on real world experience and our focused on requirements often found for methods used in pharmaceutical industry Quality Control Laboratories.  


WHO SHOULD ATTEND

Analytical chemists developing HPLC methods to validate for the first time, chemists who need a refresher in the techniques, or managers involved in the supervision of methods development and validation will benefit from this course. QA personnel who review data from validations will also find this course very useful.


COURSE OUTLINE

1.      Introduction to HPLC Method Development

2.      Defining End User Requirements and Separation Goals

3.      Globally Evaluating Analyte and Sample Matrix

4.      Sourcing Existing Data Regarding Separation

5.      Sourcing New Data Regarding Separation

6.      Defining Screening Experiments

7.      Executing Screening Experiments

8.      Performing Screening Experiments

9.      Evaluating Screening Separations

10.  Modifying and Performing Additional Screening Experiments

11.  Evaluating Final Screening Separations

12.  Finalizing the Separation

13.  Performing a “Method Sanity Check”

14.  Creating a Draft Method

15.  Designing a Limited Robustness Study

16.  Executing Limited Robustness Study

17.  Generating Methods Development Report

18.  Promulgating the Methods Development Report

19.  Summary

20.  Questions and Answers

 ADMINISTRATION

The course is one day in length. Cost is $525 per person, with a ten-student minimum for on-site presentation. Payment can be made by personal check, company check, purchase order, or by MasterCard, Visa, or American Express. Registration can be made on-line or via telephone.

 

 

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