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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

ICH Stability Testing and Method Development

Published Date: April 29, 2020

Presenter: Shiri Hechter, Nelson Labs Fairfield

Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. This presentation will provide a brief overview of the ICH guidelines for Stability testing, as well as aspects of analytical method development.

Shiri Hechter

Shiri Hechter

Chemistry Manager, M.Sc., ASQ CQA and CSSGB

Shiri Hechter is an organic chemist. She received her master’s degree in organic chemistry from Tel-Aviv University in 2005. She began her career at Gibraltar Labs in 2006. She started as a Chemistry Group Leader in the analytical chemistry department.  After two years, Shari was promoted to the QA department as a Quality Assurance deputy...

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