USP–NF General Chapter 1210 Statistical Tools for Procedure Validation (Classroom)

Event

Course Description:

This course introduces key components of USP–NF General Chapter <1210> Statistical Tools for Procedure Validation. This chapter provides statistical concepts used for procedure validation and complements USP–NF General Chapter <1225> Validation of Compendial Procedures. The course will include an overview of USP <1225>.

Upon completion of this course, you will be able to:

  • Identify the performance characteristics of analytical procedures described in USP <1225>
  • Define “fit for purpose” with respect to a procedure
  • Identify methods and statistical tools used for procedure validation
  • Correctly apply statistical tools and methods used to validate bioanalytical procedures
  • Recognize and avoid common actions that can result in compliance issues during statistical validation

Who Should Participate:

  • Analytical chemists
  • QA/QC staff
  • R&D staff
  • Project management staff
  • Manufacturing staff
  • CROs
  • Regulatory professionals
  • Technical liaisons who are involved in the validation and verification of analytical procedures

NOTE: You should have at least two years’ experience in the pharmaceutical industry to get the full benefit of this course.