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Considerations for Method Validation

Published In: Pharmaceutical Technology

In this article published in Pharmaceutical Technology, Susan Schniepp and Shiri Hechter explain how an analytical method to be used for routine testing but not published in a pharmacopeia can be validated.


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Shiri Hechter

Shiri Hechter

Analytical Chemistry Testing Expert

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


Susan Schniepp

RCA Distinguished Fellow, Regulatory Compliance Associates

Susan has over 40 years of quality-assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award. Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011 to 2013 and from 2016 to 2019 and is currently the Chair of the board of directors. She has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing-data-integrity issues and participating in PDA’s ANSI's standard-setting activities regarding purchasing controls and quality culture.