Validation, Verification and Transfer of Analytical Procedures (Live Webcast)


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 ICH guidelines. Elements on Method transfer and the complementary chapter USP−NF <1210> Statistical Tools for Procedure Validation will also be discussed in this course.

Upon completion of this course, you will be able to:

  • Understand how approaches to validation depend on the intended application of the procedure
  • Learn when each is appropriate - validate versus verify
  • Evaluate the characteristics to consider for validation of various analytical procedures
  • Gain an understanding of the design of validation experiments and interpretation of results
  • Understand how to review techniques to minimize resources required
  • Gain an understanding of the different approaches for transfer of procedures
  • Understand the differences and the relationship 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.