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>.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Identify the performance characteristics of analytical procedures described in USP <1225>
• Define “fit for purpose” of 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

Target Audience (If applicable):
• 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