Course Description
Learn about parameters for validating analytical procedures for small molecules based on USP-NF General Chapters <1225> Validation of Compendial Procedures and <1226> Verification of Compendial Procedures. Topics include comparing <1225> and <1226> and understanding the differences between <1225> and ICHguidelines.
There will be a knowledge assessment at the end of the course. If this course is taken as part of the USP certificate program, 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. The live version of this recording took place on February 1, 2018. This course includes English subtitles.
Upon completion of this course, you will be able to:
- 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
Who Should Participate:
Analytical chemists
QA/QC
R&D
Project management
Manufacturing Staff
CROs
Regulatory professionals
Technical liaison, who are involved in the validation and verification of analytical procedures.
NOTE: You must have at least 2 years experience in pharmaceutical industry to get the full benefit of this course.
The accompanying USP General Chapter(s) available as resources with this on-demand course, were official as of this date. Please check www.uspnf.com for relevant updates.
Access Duration: Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Why Choose USP Education?
USP Education provides year-round courses and programs on how to effectively interpret and apply USP’s internationally recognized quality standards. The standards help ensure the quality and safety of medicines, dietary supplements and foods.
USP courses are created by the scientists and experts who help develop the USP standards that are used worldwide. Courses are presented by approved instructors with practical, first-hand knowledge of the subject area and related standards. The insights they share will not only make your daily work easier, but will also connect you to an independent, nonprofit scientific body with the goal of creating a strong foundation for a healthier world.
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USP Approved Instructor
![](/clientimg/uspharmacopeia/welcome/PE%20Instructor%20Photos/Horacio%20Pappa.jpg)
Horacio Pappa
USP Employee since 2003
Director, General Chapters
Pharmacy, University of Buenos Aires
Ph.D., medicinal chemistry, University of Buenos Aires
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