Analytical Method Validation Process

Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.

This webinar will explain the validation of analytical procedures for determining the suitability of a given methodology for providing useful analytical data.

Why should you Attend: Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug or other products.

• Process to validate method
• Components of method validation
• Regulations USP / ICH / FDA
• How we know what FDA is looking for
• How to use Quality by Design (QbD) to enhance Analytical Method Validation

• Method Development, Optimization and Validation Approaches
• Method Validation -High Level
• System Suitability
• Validation Components
  • Accuracy
  • Precision
  • Repeatability
  • Interm. Prec.
  • Specificity
  • LOD
  • LOQ
  • Linearity
  • Range
• LifeCycle Concept
• Validation Planning