Course Catalog

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

This course will guide you step-by-step through the concepts, techniques and tools necessary to develop validated HPLC methods. You’ll 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, you’ll be taught a streamlined, iterative process to integrate the method development and validation activities.

In addition, by examining case studies in this course, you’ll learn about specific problems and how to approach them. You’ll be learn to carry out routine maintenance to prevent loss of validation, and how to set diagnostics to recognize behavior that requires troubleshooting.

Course Details

Key Topics

  • How to implement a systematic approach to method development
  • How to assure continual validation of HPLC methods by building in ruggedness, and monitoring with statistical process control tools
  • How to achieve effectiveness, efficiency, productivity, and reduced costs
  • How to interpret ICH and other guidelines for method validation
  • How to use statistics to demonstrate validity
  • How to learn from case studies using practical examples
  • How to carry out routine maintenance and component testing practices that are helpful to preventing loss of validation
  • How to set diagnostics to recognize behavior that requires troubleshooting

Information

This course will guide you step-by-step through the concepts, techniques and tools necessary to develop validated HPLC methods. You’ll 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, you’ll be taught a streamlined, iterative process to integrate the method development and validation activities.

In addition, by examining case studies in this course, you’ll learn about specific problems and how to approach them. You’ll be learn to carry out routine maintenance to prevent loss of validation, and how to set diagnostics to recognize behavior that requires troubleshooting.

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, petroleum, environmental, foods, flavors, fragrances, pesticides, testing services laboratories, and occupational health and safety testing will benefit.

Benefits

  • Discuss your specific method development/validation problems with instructors who have more than 60 years of combined experience in industry and academe
  • Learn how to develop rugged HPLC methods in a timely, cost effective manner
  • Solve real HPLC method development problems and troubleshooting problems using tools presented in the course
  • Understand trade-offs and choices for determining validation parameters
  • Learn where statistics intersect practice for successful validation
  • Understand systematic troubleshooting of HPLC methods in a cost effective manner
  • Learn how to anticipate method validation and quality assurance when developing HPLC methods
  • Learn how to select the best techniques/components at the beginning
  • Understand how HPLC components work and contribute to the method
  • Learn how to detect and correct problems before the method becomes invalid
  • Leave with a firm strategy for developing your own continually validated HPLC methods

Agenda

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

Course Locations

Date

TBA

Check-in opens at 7:30 a.m. on the first day of the course.

Course runs from 8:30 a.m. to 5:00 p.m. each day.

Register Online Register Via Mail

Venue

TBA


Pricing
Advanced $850
Standard $1,150

The course fee includes a course binder and a continental breakfast each day.

Five for Four! Register five people for one course, one person for five courses, or any combination in between and your fifth registration is free. Note: This discount is only available if you register by fax, mail or phone and mention this discount and may not be combined with any other offer.

About the Instructors

  • Stanley N. Deming

    is Professor Emeritus of Chemistry at the University of Houston, Houston, Texas.

  • Brian A. Bidlingmeyer, Ph.D.

    is the Separations Business Manager for HPLC Columns at Agilent Technologies.