Validation of Compendial Procedures

Background

Current educational offerings centered on compendial method validation do not provide adequate direction set by the Expert Committee when describing critical performance properties. Additionally, relevant USP-NF General Chapters, outside of Chapter <1225> are not addressed and therefore are limited in the scope of applicability.

Course Description

The new Validation of Compendial Procedures will comprehensively address USP's validation requirements. Focusing on the types and characteristics of the analytical procedures utilized to demonstrate compliance, the student will have an opportunity to define the characteristics of validation procedures, design experiments to consider those characteristics and interpret the results using a statistically-based methodology. The distinctions between verification and validation will be reviewed and the requirements for validation of alternative methods will be addressed. Practical applications to set-up and examine the results of an experiment are included.

Who Should Participate

Scientists, chemists and those who perform or manage validation procedures.

Format / Duration

Classroom / 1 full day

Learning Objectives

  • Determine the purpose of the analytical procedure and the type of validation procedure to be used
  • Outline the characteristics to consider for validation of various analytical procedures
  • Design an experiment and interpret the results
  • Validate and document an alternate to an official method