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Introduction

The lifecycle and Quality-by-Design concept, which has been in the focus of the International Council of Harmonisation (ICH) since the mid-2000 years (ICH Q8-12, EU and FDA Process validation guidelines) is increasingly adopted concerning analytical procedures. The hallmark of this concept is a comprehensive and enhanced understanding of the analytical procedure performance. This is holistically described in the USP General Information Chapter (May 2022), and in just published new ICH guideline Q14 “Analytical procedure development”. To pursue such an enhanced approach, an appropriate understanding of statistical parameters and approaches is essential.

This course will offer the participants an overview of statistical fundamentals such as data distributions, descriptive and predictive parameters, and with practically relevant statistical tests and calculations, including the new assessments described in the just published revision of ICH Q2 “Validation of analytical procedures”, e.g. an “appropriate 100(1-α) % confidence interval (or justified alternative statistical interval ) … should be compatible with the corresponding … acceptance criteria”, or “Combined accuracy and precision can be evaluated by use of a prediction interval, a tolerance interval or a confidence interval.”

Who Should Attend

Meet The Trainer

Following a study of biochemistry and a Ph.D. thesis in enzyme kinetics, Dr. Ermer started his career in pharmaceutical analytics and industrial Quality Control in 1991. He held various positions, including head of the laboratory within the analytical drug development at Hoechst AG, Frankfurt, Germany, and from 2001 to 2005 a global function as Director of Analytical Processes and Technology. This included consultation, harmonization, troubleshooting, and training of all industrial sites of Aventis to Quality Control topics. From 2005 to 2010, he served as head of Quality Control Frankfurt Chemistry, Sanofi, Germany. Between 2010 and 2018, Dr. Ermer was head of QC Services which included a reference standard group with the mission to provide company-wide management and distribution of analytical reference standards. 

From 2018 to 2020, he held the responsibility as head of QC Lifecycle Man[1]Management Frankfurt Chemistry and evaluated compendial and regulatory changes, supported and coordinated analytical transfers, validation, and implementation projects, in particular the establishment of a quality system and routine monitoring program for continuous performance verification of all API-methods. Dr. Ermer is a member of the USP Expert Committee “Measurement and Data Quality“, the Ph. Eur. Working Group “Chromatographic Separation Techniques”, and an Advisory Board member of the ECA Analytical Quality Control Group. He authored more than 60 publications on analytical topics and is the editor and author of the two editions of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005 and 2015).

Dr. Joachim Ermer

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