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.
Upon completion of this course, you will be able to:
- 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
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 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Horacio Pappa
USP Employee since 2003
Director, General Chapters
Pharmacy,