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Introduction
The lifecycle and Quality-by-Design approach has eventually (formally) arrived in the scope of pharmaceutical analysis and Quality Control, as obvious by the USP General Information Chapter <1220> “The analytical procedure lifecycle” (valid since May 1, 2022), and the new ICH guideline Q14 “Analytical procedure development” (November 2023). Before, it has been in the focus of pharmaceutical manufacturing since the mid 2000 years (ICH Q8-12, EU and FDA Process validation guidelines).
The hallmark of this concept is a comprehensive and enhanced understanding of the analytical procedure performance, starting with analytical procedure development, demonstrating an appropriate performance before routine application of the analytical procedure (as outlined in the new revision of the ICH Q2 guideline “Validation of
analytical procedures” (November 2023), and continuing during the whole lifecycle. Such an enhanced understanding across the whole lifecycle is beneficial for continual improvements, and enables in particular to focus the activities where it is really needed, in an objective, data-based manner.
Who Should Attend
- This course is designed for analysts and managers in Quality Control and Quality Assurance responsible for investigating, ensuring, and assessing analytical performance throughout the lifecycle, as covered by the new ICH guidelines Q14 and Q2(R2), i.e. in method development, validation, transfer, specification setting, batch release and stability, ongoing performance verification and change control. Manufacturing and regulatory affairs representatives can benefit from participation by improving their understanding of analytical performance parameters and their calculations which are important to implement scientifically sound and pragmatic approaches to conform to GMP and regulatory requirements, for example in case of the Annual Product Review.
Key Takeaways
The attendee will be able to :
Meet The Trainer
Following study of biochemistry and PhD 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 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, trouble-shooting and training of all industrial sites of Aventis with respect 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 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 programme for continuous performance verification of all API-methods.
Dr. Ermer is member of the USP Expert Committee “Measurement and Data Quality“, the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group. He authored more than 60 publications on analytical topics and is 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). The third edition is in preparation and scheduled for publication mid-2024.
