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.