Pharma Science

Principles of HPLC Validation - Training Module 1: Introduction

A short course in the systematic validation of HPLC methods. We start by taking an overview of the validation process and review some of the key references that will be useful in setting up a validation process. We also discuss the terminology and some important measurements that will be encountered during validation.

This course is designed for laboratory personnel responsible for validating HPLC methods. It will also be useful for managers and quality assurance staff involved in the method validation process. For workers who develop, but do not validate methods, this class will give insight into how to develop methods that will be easier to validate. No prior experience is needed, although those with some laboratory experience will certainly benefit more than those with no experience at all.

ats-STRIP

This course covers:

We start by taking an overview of the validation process and review some of the key references that will be useful in setting up a validation process. We also discuss the terminology and some important measurements that will be encountered during validation.

  • Introduction & Resources 
  • Steps in Validation
  • Quality
  • Chromatography Basics 
  • Terminology

By attending this online training course you will understand how to re-validaterganize a validation project. By planning ahead, you will see how to develop better methods that will validate more easily and will function more reliably in routine use. You will realize how by using Quality by Design principles during development, the methods will be easier to validate and be more robust in routine use. You will learn how to decide which variables are important and which ones are not. You will see how software tools can help you to get much more mileage out of your experimental runs. You will gain a better understanding of the calibration process and how to examine data for problems. Learn when method adjustments are allowed without re-validating the method. Find out why uncertainty plays such a big role in validation.

You will be able to answer these questions upon completion of the course:

  • What is the best description of HPLC method validation?
  • Where should you look for directions on how to validate an HPLC method?
  • Why is method development often considered a part of validation?
  • What is the purpose of prevalidation?
  • Why do deviations need to be documented during a validation?
  • What is a validation protocol?
  • Which statement describes the quality of a method?
  • Who is responsible for quality the laboratory?
  • How does instrument calibration fit into the requirements for producing high quality data from the laboratory?
  • What is the k-value of a peak that has a retention time of 4 min when the solvent front (t0 or tM) appears at 1 min?
  • What is the closest value of the separation factor, α, between two peaks with k-values of 3 and 4, respectively?
  • Which is the best estimate of the resolution between two peaks with retention times of 3 and 4 min and 0.45 and 0.55 min, respectively?
  • How can excessive peak tailing compromise analytical results?
  • What is the difference between precision and accuracy?
  • What is specificity of an analytical method?
  • What is the best statement of the limit of detection (LOD, DL)?
  • What is the best statement of the limit of quantification (LOQ, LLOQ, QL)?
  • Describe the requirement for linearity of a method?

 

Principles of HPLC Validation - Available at USD98 Validate HPLC methods for  the analysis of pharmaceutical drug substance, drug product, impurities, and  degradation products.

 

    

Subscribe to FREE learning from the experts!