Dr Christian Palmes
Bayer AG
Referierende
Highly Interactive Training: Hands-on Exercises and Guided Minitab Sessions
- - Plan and analyze pharmaceutical DoE case studies using Minitab
- - Understand main effects and interactions using Excel calculations
- - Optimize processes and derive Design Spaces using Response Surface Methodology
- - Guidelines covered: ICH Q8, Q11, Q14 and Pharm. Eur. Supplement 11.7
Zielgruppe
This course is intended for employees in development, quality control laboratories, process engineering and quality assurance who currently use DoE or plan to apply it in the future. It is also suitable for GMP auditors, inspectors and validation personnel involved in reviewing DoE studies or regulatory submissions. A basic understanding of statistics is helpful, but no advanced statistical knowledge is required.
Remark: The number of participants is limited to ensure effective hands-on training.
Remark: The number of participants is limited to ensure effective hands-on training.
Zielsetzung
This DoE course offers a clear, hands-on introduction to planning and analyzing experiments using Minitab. It features four pharmaceutical case studies presented in a fully guided, step-by-step format.
DoE theory is covered at a practical level, enabling participants to understand the key concepts, interpret software outputs correctly and draw sound conclusions from experimental data.
- Day 1 focuses on the planning stage of DoE
- Day 2 focuses on the analysis of DoE results
The course covers a broad range of classical and modern DoE designs, including full and fractional factorial, Plackett-Burman, central composite (RSM), D-optimal and mixture designs.
Background
Design of Experiments (DoE) is a key statistical methodology in Quality by Design (QbD). It supports the systematic investigation of process parameters and quality attributes, helps identify critical factors and provides a scientific basis for defining robust operating ranges and Design Spaces in line with regulatory expectations.
Programm
Day 1
Welcome and Course Introduction
- Short round of introductions
- Objectives of the training
Principles of DoE Planning: Part I
- General considerations – why DoE?
- OFAT (One-Factor-at-a-Time) versus DoE
- The DoE workflow
- Experimental goals
- Main, interaction and quadratic effects
Introductory Example: Optimizing a Cake Recipe
- Get familiar with DoE in Minitab
- Plan and evaluate a factorial experiment in Minitab
- Understand main and interaction effects using Excel calculations
Principles of DoE Planning: Part II
- Randomization, blocking, replication and center Points
- Power, sample size and orthogonality
- Fractional factorial designs: resolution III, IV and V
- Plackett-Burman and central composite designs
- Special designs: D-optimal, I-optimal and mixture designs
Case Study: Filtration Rate Optimization: Planning
- Plan a full-factorial design in Minitab
- Assess signal-to-noise ratio, correlation and effect sizes
- Use Minitab’s DoE planning tool
Hands-on Exercise: Planning a DoE Study
- Plan a DoE on your own
- Case Study 1: Optimization of a granulation process
- Case Study 2: HPLC robustness assessment
Day 2
Building and Assessing Statistical Models
- Effect selection
- Analysis of variance (ANOVA)
- Model building and interpretation
- Statistical significance, p-values and model terms
- Confidence, prediction and tolerance intervals
- Data and model visualizations with Minitab
Model-Based Prediction, Design Space, and ICH Q8
- Goodness of fit and predictive performance
- Lack-of-fit and curvature
- Predicted values and residuals
- Transformations (Box-Cox)
Case Study: Filtration Rate Optimization: Analysis
- Effect selection for model building
- Interpretation of model diagnostics
- Derivation and assessment of the Sweet Spot and Design Space
Hands-on Exercise: DoE Analysis
- Analyze the HPLC or granulation DoE case study
- Derive a Sweet Spot and Design Space in line with ICH Q8
Supplementary Material: Design Augmentation
- Questions and elaborated sample Solutions
- Simultaneous optimization of three responses with two factors
- Design augmentation to incorporate quadratic effects
- Circumscribed central composite designs in Minitab
- Design Space and Sweet Spot derivation using overlay plots
Weitere Informationen
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members EUR 1,890
APIC Members EUR 1,990
Non-ECA Members EUR 2,090
EU GMP Inspectorates EUR 1,045
The conference fee is payable in advance upon receipt of invoice.
Supplementary Material: Participants will receive an additional DoE case study as homework to reinforce the course content.
Pre-requisites:
Each participant should have access to a computer with current versions of Excel and the desktop version of Minitab installed. A time-limited free trial of Minitab is available from http://www.minitab.com. The software should be downloaded and tested a few days before the course starts to ensure that it works properly.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Sven Pommeranz +49 6221 84 44-47, pommeranz@concept-heidelberg.de
Questions regarding organisation:
Mrs Julia Grimmer +49 6221 84 44-44, Julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 06 October 2026, 08:30-17:30 h
Wed, 07 October 2026, 08:30-17:00 h
Wed, 07 October 2026, 08:30-17:00 h
All times mentioned are CEST
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 Validation Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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