Ongoing Monitoring within the Analytical Procedure Lifecycle
Online Masterclass
- September 24th - 25st 2024
- 09:00 AM - 01:00 PM (EST)
Trainer
Dr. Joachim Ermer
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Introduction
The hallmark of the lifecycle concept is a comprehensive and enhanced understanding of the analytical procedure performance, as discussed in the USP General Information Chapter <1220> “The analytical procedure lifecycle” (valid since May 1, 2022), the new ICH guideline Q14 “Analytical procedure development” (November 2023) and the new revision of the ICH Q2 guideline “Validation of analytical procedures” (November 2023). The analytical lifecycle starts with considerations of the required analytical performance to measure the respective Quality Attribute (i.e. the Analytical Target Profile, ATP) and the selection of an appropriate analytical technique (ICH Q14).
In Stage 1 (Analytical Procedure Design), the method is developed and optimized applying Quality-by-Design (QbD) principles (ICH Q14). Stage 2 (Procedure Performance Qualification) consists of demonstrating suitability (i.e. an appropriate performance as defined in the ATP) in the intended routine environment, which includes (traditional) validation (ICH Q2(R2)), but also verification of compendial procedures, as well as analytical transfer.
Who Should Attend
- QA involved in Annex 1 compliance and those facing GMP inspectors and auditors
- QC (QC Microbiology and Chemistry)
- Qualified and Responsible Persons (QPs, RPs)
- Production operations: All levels; supervisors and lead operatives
- Materials, Science and Technology groups
- Maintenance leads that support production operations
- Engineering, Validation, and Qualification teams
- GMP consultants and GMP trainers
- Process equipment, Barrier Technology designers, and manufacturers
- Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organisations (CDMOs)
Target Audience
- 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.
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.
