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.

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.

BIOGRAPHY 

Margareth R. C. Marques 

Principal scientific liaison at the Science Department at the United States Pharmacopeia. Scientific liaison to the USP Expert Committee on Dosage Forms working on general chapters for performance tests (dissolution/drug release), and for some pharmaceutical dosage forms (products applied to the skin, ophthalmic products, etc.), responsible for the USP general chapters on osmolality, titrimetry, and UV/Vis spectrophotometry.

Dr. Marques is also responsible for developing specifications for reagents, test solutions, buffer solutions, etc., used in USP – NF monographs. She manages the USP database on chromatographic columns, the USP database on dissolution methods and the USP web site on column equivalency. She has a B.Sc. and an M. Sc. both in Pharmacy by the University of Sao Paulo, Brazil. She has a Ph. D. in Analytical Chemistry by the State University of Campinas, Brazil. She managed analytical laboratories at Ciba-Geigy, Sandoz, and Astra.