Analytical Lifecycle Management

In this Webinar Learn
Development towards life cycle approaches (ICH, manufacturing)
Application to analytical procedures (EFPIA working group, USP, FDA Method Validation Guidance)
USP 1220 Draft: Analytical Target Profile (ATP) and 3-Stage approach
1. Analytical procedure design
2.Procedure performance qualification
3.Ongoing procedure performance verification
ICH Q12
1.Established Conditions for analytical procedures
2.Structured approach for immediate implementation of changes
3.Post-Approval Change Management Protocol: practical value?
4.How much regulatory flexibility and harmonisation can be expected?
ICH Q2 Revision and new Q14 Guideline
About the Presenter - Dr. Joachim Ermer
Dr Ermer is the CEO of Ermer Quality Consulting. He has almost 30 years of experience in pharmaceutical analytics in drug development, global quality functions, and head of industrial QC. He is member of the
1. EFPIA Working Group - Analytical Lifecycle Management (2008 - 2020), 2018 reorganised as EFPIA ICH Q2/Q14 Support Team
2. USP Expert Panel Validation and Verification (2011-2018) and USP Analytical Procedure Lifecycle Expert Panel (2019 - 2020)
3.USP Expert Committee Measurement and Data Quality (since 2020)
4.Ph.Eur. Chromatographic Separation Techniques Working Party (since 2020)