USP Certificate of Pharmacopeial Analysis
The USP Certificate of Pharmacopeial Analysis provides prospects with the knowledge necessary for analytical validation, verification and transfer and the statistical tools to support these activities. In addition, students will gain an understanding of ICH Q2 guideline and the differences and similarities between USP General Chapters <1224>, <1225> and <1226>.
This certificate includes USP–NF General Chapters <1224>, <1225>, <1226> and ICH guideline.
There will be a knowledge assessment at the end of each course in this certificate. You will be required to pass this knowledge assessment with a score of 80 percent to determine if your comprehension of the topics presented meets USP’s minimum requirements.
Upon completion of the USP Certificate on Impurities, you will be able to:USP General Chapter 1210 - Statistical Tools for Procedures Validation:
- Identify methods and statistical tools used for procedure validation
- Demonstrate correct application of statistical tools and methods used to validate bioanalytical procedures
- Recognize and avoid common actions that can result in compliance issues during statistical validation
Validation, Verification and Transfer of Analytical Procedures:
- Interpret how approaches to validation depend on the intended application of the procedure
- Identify when each is appropriate—validate vs. verify
- Evaluate the characteristics to consider for validation of various analytical procedures
- Describe the design of validation experiments and explain the interpretation of results
- Identify how to review techniques to minimize resources required
- Discuss the different approaches for transfer of procedures
- Explain the differences and the relationship among validation, verification, and transfer of analytical procedures
Target Audience
QC/QA personnel and management, regulatory compliance personnel and management, analytical scientist and workbench chemists responsible for quality assessments, regulatory agencies
Access Duration:Access to this course expires 2 months 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.