Analytical Methods Validation Parameters According to USP-NF General Chapters <1225> Compendial Procedures Validation, <1226> Compendial Procedures Verification, and <1224> Analytical Procedures Transfer.
Differences between General Chapters <1225> and <1226> and the ICH guides. Topics related to the transfer of analytical methods and the General Chapter of USP-NF <1210> Statistical tools for validation of procedures. In addition, this course addresses local legislation with regard to applied statistics in the validation of analytical methodology present in RDC166/17 through case studies.
Couse Duration (hh:mm:ss): 16:00:00
Margareth Marques – Principal Scientific Liaison, U.S. Pharmacopeia
Rafael Maranho – Strategic Customer Development Executive – U.S. Pharmacopeia
Raphael Sanches Pereira – Gerente de Avaliação da Qualidade de Medicamentos Sintéticos – ANVISA
Gabriel Nunes Silva – Regulatory Affairs CMC Specialist – Servier