CAS in Quality by Design

Key enablers for QbD implementation are Quality Risk Management and Knowledge Management as described in ICH Q10: a new concept of quality is hence defined putting together the approaches and the tools described in ICH Q8, ICH Q9, ICH Q10 and ICH Q11 up to the most recent ICH Q12. The scientific knowledge requested by QbD implementation cannot be realised without a new approach to data, and data management: the implementation of improved statistical tools to approach quality is hence requested.

CAS Quality by Design

Module 1: Introduction to Quality by Design (12 hour-lecture, 1 ECTS)
- Background and drivers for QbD
- Overview of the Regulatory framework and reference ICH guidelines (Q8, Q9, Q10, Q11 and Q12)
- QbD roadmap
- Learning specific terms and their meaning

Module 2: Basic Statistics (24 hour-lecture, 2 ECTS)
- Most used tools and software pros and contra (WEKA, Minitab, Statgraphics, Excel, R, Python)
- Basic statistics: Mean variance and standard deviation. Formulation and testing of the Null hypothesis, understanding false positives and false negatives, the contingency table.
- Sample size and power of a test
- Comparison of samples with known and unknown variance
- Simple and multiple linear regression
- Logistic regression
- ANOVA
- Outliers and Influential points detection and treatment
- Model evaluation and validation
- Optimisation and automatic selection of variables
- Examples, real-life practical cases

Module 3: Introduction to Design of Experiments (24 hour-lecture, 2 ECTS)
- Definition of experimental plan: responses, type of factors and degree of interaction
- Complete two-level factorial plan (addition of centre points, replication and reduction)
- Model validation (residuals analysis, curvature, lack of fit)
- Block and confusion
- Fractional factorial plans
- Robustness testing
- Introduction to response surface design, mixture design and optimisation
- Case studies

Module 4: Risk and Project Management for QbD (12 hour-lecture, 1 ECTS)
- Project Management Foundations, Introduction and general considerations: Project Definition, Project Charter, Assumptions, Constraints, Requirements, Scope Management, Project Team, Stakeholder Management, Communication Management
- Risk Management Foundations: Risk Identification, Qualitative and Quantitative Risk Analysis, Risk Response, Risk Register

Module 5: QbD elements (12 hour-lecture, 1 ECTS)
- What information to collect and when?
- Product and process design; TPP; QTPP
- Identification of CQA; CMA; CPP and the role of Risk Management in the whole process
- Case studies

Module 6: Quality by Design in scale up and technology transfer (12 hour-lecture, 1 ECTS)
- Exploitation of knowledge acquired in design: process design, facilities, equipment, material and manufacturing variables
- Design Space definition
- Control strategy
- Transfer protocol and report according to QbD

Module 7: Process validation and continuous verification in QbD (12 hour-lecture, 1 ECTS)
- Regulatory framework: EU vs FDA: requirements and specific terminology
- Using acquired knowledge
- Control strategy in PV, statistical techniques for PV

Module 8: Process and Product Life Cycle Management (12 hour-lecture, 1 ECTS)
- QbD for analytics
- Change management and ICH Q10
- ICH Q12

23 May 2025: 8.30-16.30 in Bern
Final Exam in Bern

• Insbesondere werden folgende Fachpersonen respektive Berufsgruppen angesprochen: Labortechniker/innen, Forschungs- und Entwicklungsleitende in den Bereichen Physik, Chemie, Pharmazie und Medizinalprodukte
  
  
• Führungskräfte, Bereichsleitende und Entscheidungstragende, die sich über Methoden, Konzepte und Instrumente zur Verbesserung der Unternehmensstrategie und der Wettbewerbsfähigkeit informieren möchten.
  
  
• Qualitätsmanager/innen, Verantwortliche in der Industrieverwaltung und in den Produktionseinheiten, Manager/innen von Leistungsverbesserungsmassnahmen oder von Produktionsabteilungen

Start date: November 21st, 2024
Finish date: May 23rd, 2025

sara.vignati@supsi.ch
SUPSI, Department of innovative technologies
Polo universitario Lugano, Campus Est
Via La Santa 1
CH-6962 Lugano-Viganello
Tel. +4158 666 65 11
e-mail dti.fc@supsi.ch

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