Course Description:
Learn about the validation parameters of analytical methods according to the USP-NF General Chapters <1225> Validation of Compendial Procedures, <1226> Verification of Compendial Procedures, and <1224> Transfer of Analytical Procedures.
Differences between General Chapters <1225> and <1226> and ICH guides will be addressed. Topics related to the transfer of analytical methods and the USP-NF General Chapter <1210> Statistical Tools for Validating Procedures will also be covered. In addition, this course will address local legislation with regard to statistics applied in the validation of analytical methodology present in RDC166/17 through case studies, in addition to bringing the main challenges of the industry in the validation, verification and transfer of methods.
Date: March 20th, 21th, 22th and 23th, 2023
Couse Duration (hh:mm:ss): 16:00:00
Instructor:
Margareth Marques – Principal Scientific Liaison, U.S. Pharmacopeia
Rafael Maranho – Strategic Customer Development Executive – U.S. Pharmacopeia