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>.
The live version of this recording took place on November 17, 2020.Includes English subtitles.
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.Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Steven Walfish
USP employee
M.S., statistics, Rutgers University
MBA, Boston University
B.A., statistics, University of Buffalo