Programme 16 September 2020
13.00 – 13.15 h
Welcome and Introduction
13.15 – 14.00 h
The Revision of ICH Q2 and Development of ICH Q14
- Important gaps and deficiencies in current ICH Q2(R1)
- Content of the draft Guidelines Q2 / Q14
- Expectations for Q2 revision and Q14
14.00 – 15.30 h
Product Life Cycle Concept from the Perspective of the Authorities - Focus: New Approaches in Process Development/Validation & Production Routine
- Quality by Design Lifecycle
- Realtime Release Testing
- Modern Process Analysis
15.30 – 15.45 h Break
15.45 – 16.15 h
Description of analytical Procedure and Validation, a Regulator’s View
- Development of analytical method vs validation of analytical method
- Overall control strategies
16.15 – 16.45 h
How to establish an Analytical Target Profile (ATP) for Small Molecules
- What needs an ATP
- When to Establish ATPs
- How to Write ATPs
- How to Use/Update ATPs
16.45 – 17.15 h
How to establish an Analytical Target Profile (ATP) for Large Molecules
- ATP as the corner stone of the analytical procedure development strategy
- How to set up an ATP for methods applied to biologics
- Case studies
17.15 – 18.00 h
Questions & Answers
Programme 17 September 2020
08.30 – 09.00 h
How Software Tools can support QbD Method Development
- Modern Quality-by-Design approach
- Statistical concepts with experimental design plans (also referred to as Design-of-Experiments) as an efficient and fast tool for method development
- Multivariate data analysis software package Fusion QbD®
- Chromatography simulation software DryLab®
- Workflow and examples in using software packages for method development
09.00 – 09.45 h
The ECA APLM Guide
- The ECA Analytical Quality Control Group
- Interactions between the Groups within ECA
- Drivers for and the process of the guideline development
- Contents and structure of version 1 July 2018
- Going forward; the journey to version 2
09.45 – 10.00 h Break
10.00 – 10.45 h
Verifications of Compendial Methods in Pharmaceutical QC
- Requirements for verification of compendial methods
- Verification versus validation versus analytical transfer
- Life cycle approach for compendial methods
- Design ranges for compendial methods
- Typical verification approaches
10.45 – 11.30 h
Analytical Lifecycle Management using an enhanced versus traditional Approach
- ATP, DOE and MODR on a case study
- Risk-based approach and patient impact considerations
- Analytical method changes post approval
11.30 – 12.00 h
Questions & Answers
12.00 – 13.00 h Break
13.00 - 13.45 h
Robustness and DoE
- Experimental Design
- Method Optimisation – Response Surface Designs
- Robustness Testing – Fractional Factorial Designs
- Ruggedness Testing – Measurement Systems Analysis
- Equivalent Testing – Two One Sided Tests
13.45 – 14.30 h
Validation for MAA/NDA. Planning and Execution
- Overview of relevant guidelines, pharmacopeial monographs
- ICH Q2 current version
- Practical Aspects of Method Validation (incl. examples)
14.30 -14.45 h Break
14.45 – 15.30 h
TMU (Target Measurement Uncertainty)
- Stimuli Article by USP
- Deriving TMU from Specification
15.30 – 16.15 h
How to establish an efficient and relevant continued Performance Monitoring Program in pharmaceutical Analysis
- What method performance information is available? (conformity, validity, numerical performance parameter)
- Identification of performance characteristics relevant for the analytical procedure: exploitation of available routine data
- Use of control charts
- Assay of control batches (virtual and concrete)
- The power of multiplicity: Calculation of long-term performance parameters (precisions)
16.15 – 17.00 h
Questions & Answers