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

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