One-Day Course
Date to be announced; 8:30am – 5:00pm
Richard Verseput, S-Matrix Corporation, Eureka, CA
COURSE DESCRIPTION:
Current USP and ICH guidances affirm the expectation of quantitation and statistical rigor in analytical procedure development. This course describes strategic Analytical Quality by Design (AQbD) tools and methods in these guidances which 1) can be quickly implemented in the lab, 2) generate easily interpretable data and results, and 3) provide the sound, statistically defensible knowledge needed to dramatically accelerate fit-for-purpose method development. Course topics include 1) defining the ATP as a negotiated specification incorporating analytical and production variation, 2) correctly assessing method robustness to establish a Method Operable Design Region (MODR), 3) optimizing the replication strategy to generate reportable results which will consistently meet the ATP-specified performance requirements, and 4) gaining the critical knowledge to transfer to Stages 2 and 3 of the analytical procedure lifecycle. Course topics are presented in the context of LC and LC-MS method development, validation, and transfer.
WHO SHOULD ATTEND
Laboratory directors, lab managers, analytical scientists who develop and validate analytical procedures – especially liquid chromatography (LC) methods, and anyone responsible for implementing enhanced analytical procedure development guidelines and practices in their labs.
TOPICS:
- Analytical Target Profile (ATP)
a. A negotiated performance specification based on the precision-to-tolerance ratio.
b. A bridge between surrogate and quantitation-based performance metrics.
c. Risk assessment and Design of Experiments (DoE) - Method Operable Design Region (MODR)
a. Characterizing mean performance across the entire design region.
b. Monte Carlo simulation – correctly characterizing robustness across the entire design region.
c. Identifying instrument control specifications and critical performance characteristics for use in APLM Stage 3 - Replication Strategy Optimization
a. The meaning and use of guard bands.
b. Characterization of the Total Analytical Error (TAE) and its component contributions.
c. Combining bias and precision using the USP <1210> interval metrics.
d. Generating reportable results which meet ATP-specified performance requirements - Utilizing final method development results in automation-assisted method transfer studies.
ABOUT THE INSTRUCTOR:
Richard Verseput has over 30 years of experience applying QbD tools and methods in multiple industries. For the last 18 years he has worked with analytical instrument manufacturers, regulatory agencies, and global pharma customers to develop and advance automated QbD experimentation. Richard Verseput is currently president of S-Matrix – the developer of Fusion QbD® – a regulatory compliance supporting software platform which automates QbD experimentation, peak tracking, and chromatography data modeling for the successful development, validation, and transfer of LC and LC-MS methods.
