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.

Subject area:
Drug Products & APIs

Objectives (If applicable):
•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 (If applicable):
– Analytical chemists
– QA/QC staff
– R&D staff
– Project management
– Manufacturing staff
– CROs
– Regulatory professionals
– Technical liaison, who are involved in the validation and verification of analytical procedures.
NOTE: You should have at least 2 years’ experience in pharmaceutical industry to get the full benefit of this course.