Validation, Verification, and Transfer of Analytical Procedures (On-Demand)

Curriculum

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.

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