Dr Joachim Ermer
Ermer Quality Consulting
Referierende
Patrick Jackson
GSK, UK
Dr Amanda Guiraldelli-Mahr
RIC BV
From Analytical Target Profile to Ongoing Performance Monitoring
Zielgruppe
- Analytical chemists and scientists in pharmaceutical development and validation
- Managers responsible for analytical strategy and compliance
- QA and regulatory professionals
- Academics and researchers interested in the latest developments in pharmaceutical analysis
Zielsetzung
The pharmaceutical industry is increasingly embracing risk-based approaches such as the analytical procedure lifecycle approach to enhance analytical procedure management, as highlighted in recent guidelines such as USP <1220> and ICH Q14/Q2(R2). These guidelines emphasize the integration of Analytical Quality by Design (AQbD) principles to ensure robust, reliable, and fit-for-purpose analytical procedures throughout the procedure lifecycle.
This course offers a comprehensive overview of the Analytical Procedure Lifecycle (APLC) framework, emphasizing best practices for procedure design, optimisation, and validation including the application of quality risk management principles in analytical procedure management. Key topics include defining Analytical Target Profile (ATP) performance requirements, utilizing enhanced approaches and risk assessment tools (e.g., Design of Experiments (DoE) and modelling tools) for procedure design, performing advanced robustness assessments, and using modelling to establish the Method Operable Design Region (MODR) and develop analytical procedure control strategies.
The course highlights practical approaches, supported by interactive workshops and case studies, to demonstrate the real-world implementation of these concepts for small and large molecules.
For Stage 2, Procedure Performance Qualification, practical interpretation and recommendations for demonstration of the suitability of analytical procedures is provided, including some neglected aspects in the ICH guideline Q2(R2), for example with respect to precision levels, replication strategy for the reportable result, and acceptance criteria, as discussed in the revision of the USP General Information Chapter <1225> “Validation of Analytical Procedures” (November 2025).
The suitability of an analytical procedure has to be ensured whenever applied, i.e. across the whole lifecycle. This is the aim of Stage 3, Ongoing Procedure Performance Verification, including an ongoing program for routine monitoring of analytical performance data (as discussed in the new draft USP-chapter <1221>), and the systematic evaluation of changes with the objective to evaluate regularly the need for continuous improvements. For an efficient systematic monitoring programme, it is important to identify performance-relevant parameters and information, and to understand how to apply monitoring tools (such as control charts) in a pragmatic way.
Programm
Introduction to APLC
- Developments towards lifecycle approach, alignment of process and analytics
- USP <1220>: 3 Stages of the Analytical Procedure
- ICH Q14: Analytical Procedure Development
- ICH Q2(R2), USP <1225> (rev.): Validation of Analytical Procedures
- USP <1221> (draft) Ongoing Procedure Performance Verification
- Enhanced understanding of Performance
Analytical Target Profile
- ATP concept, and its role in the Analytical Procedure Lifecycle: Linking ATP to “fitness for intended use”
- Defining Intended Purpose and Performance Expectations: Translating intended use into measurable performance characteristics
- Performance Characteristics and Performance Criteria: Setting measurable performance criteria aligned with the ATP
- Measurement Uncertainty and Risk Considerations: Introduction to measurement uncertainty, Connection to product specifications and risk-based decision-making, decision rules, fundamentals of probability in analytical risk assessment
- Defining Target Measurement Uncertainty: Eurachem approach, Monte Carlo simulations for uncertainty propagation and misclassification rate, coverage factor approach.
- Total Analytical Error: From Routine Use to Validation (combining bias and precision).
- Approaches to ATP Criteria Specification: Independent criteria vs. combined approach.
Analytical Target Profile – Small Molecules
- Practical examples
Analytical Target Profile – Large Molecules
- Practical example: Establishing ATP criteria for an rCE(SDS)-UV method for mAb size variant profiling using Monte Carlo simulation and misclassification rate
Workshop ATP (Parallel Sessions)
- Practice defining ATP criteria for methods with different intended purposes commonly used in small molecule and large molecule analysis.
- Participants can choose between two groups for parallel sessions: one focusing on small molecules, the other on biologics. Each group will work through different scenarios to define ATP criteria using various approaches.
Stage 1 Procedure Design: Introduction
- Procedure Development Approaches: minimal vs. enhanced approach, AQbD vs One-Factor at a Time (OFAT) approach
- AQbD Workflow
- Introduction to Design of Experiments (DoE) and modelling tools
- Quality Risk Management (QRM)
- Method Design Planning and strategies to select critical procedure parameters and critical procedure quality attributes (CQPAs)
- QRM tools for screening and optimization designs
Stage 1: Procedure Optimization and Robustness Assessment
- Robustness studies using traditional approach and DoE
- Strategies to design the method operable design region (MODR)
- Definition of replication strategy
- Analytical control strategies and established conditions
Workshop - Stage 1 Case Studies Risk Assessment
- Practice the establishment of a risk-based method development strategy following AQbD principles.
- Participants will apply Quality Risk Management (QRM) tools to select critical procedure parameters and attributes for screening, optimization, and robustness studies, supporting the design of a fit-for-purpose method and the definition of an operable range (MODR) enabling analytical control strategy development.
- Participants can choose between two groups for parallel sessions: one focusing on small molecules, the other on biologics.
Stage 2: Procedure Performance Qualification
- Performance characteristics, ICH Q2(R2), USP <1225>
- Precision of reportable result, science-based replication strategy
- Separate & combined evaluation of accuracy and precision
- Confidence intervals as acceptance criteria for accuracy and precision
- Use of data from development
Workshop Precision
- Understanding variability (statistical simulations)
- Establishment of the replication strategy
Stage 3: Ongoing Procedure Performance Verification
- USP <1221> (draft)
- Assessment of changes
- Monitoring programme
- Sources of performance parameters and information (performance metrics)
Stage 3: Continuous Monitoring Tools
- Control charts (Shewhart, CUSUM, EWMA, range, standard deviation)
- Statistical out-of-control rules (WECO)
- Less is more: pragmatic establishment of trending rules and limits
Stage 3: Continuous Improvement
- Regular analytical review
- Examples monitoring
- Identification of issues
Weitere Informationen
Venue
Heidelberg Marriott Hotel
Vangerowstr. 16
69115 Heidelberg
+49 6221 90 80
info.heidelberg@marriott.com
Heidelberg Marriott Hotel
Vangerowstr. 16
69115 Heidelberg
+49 6221 90 80
info.heidelberg@marriott.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 2,090
ECA Members EUR 1,890
APIC Members EUR 1,990
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments.
Non-ECA Members EUR 2,090
ECA Members EUR 1,890
APIC Members EUR 1,990
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments.
VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 17 Nov 2026, 09:00-17:30 h
(Registration/coffee 08:30-09:00 h)
Wed, 18 Nov 2026, 08:30-16:15 h
(Registration/coffee 08:30-09:00 h)
Wed, 18 Nov 2026, 08:30-16:15 h
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager"
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E-Mail: info@concept-heidelberg.de
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