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 Procedure Validation
- 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
Validation, Verification and Transfer of Analytical Procedures
- Explain how approaches to validation depend on the intended application of the
procedure - Determine the appropriate analytical approaches are appropriate (validate versus
verify) - Evaluate the characteristics to consider for validation of various analytical procedures
- Demonstrate a proficient understanding of the design of validation experiments and
interpretation of results - Describe review techniques used to minimize resources required
- Identify the different approaches for transfer of procedures
- Explain the differences and similarities between validation, verification and
transfer of analytical procedures - Identify methods and statistical tools used for procedure validation
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 6 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 c