QbD & Chemometry University of Bordeaux
This course presents the theory and methods of design of experimentapproach and assess the big data treatment with supervised and nonsupervised methods. It gives access to the bases of quality by designin pharmaceutical industry.
- Hold a bachelor or master of pharmacy or analytical chemistry withbases in analytical Chemistry and statistics - English level: B2 - Computer with excel application and internet connection
Module 1: - Oral presentation of a scientific article about QbD / 15 min / 1/3 weight of overall mark Modules 2 & 3: - Written exam: theoretical aspects and application of design ofexperiments; data analysis / 1h30 / 1/3 weight of overall mark Module 4: - Continuous Assessment during the practical class (QCM, QROC, …) / 1h (4*15min) / 1/3 weight of overall mark RULES ANDPROTOCOL FOR FAILURE- Overall mark > 10/20 - Module mark > 7.5/20
Module 1: Quality by design - Reminder of quality assurance and introduction of QbD inpharmaceutical industry - Methodology of QbD applied to analyticalmethod development - Quality of mathematical models andstatistics - Establishment of a design space and assessment byquality risk management with Monte Carlo studies Module 2: Design ofexperiments - Introduction (multivariate / monovariate approach, definition ofdifferent notions, mathematical models) - Two-level factorialdesigns - Two-level fractional factorial designs - Otherscreening designs - Order of experiments and notion of Blocking - Response Surface Designs 7 Module 3: Data Analysis - Identify methods for data analysis and processing - Principle ofclassification and clustering - Identify the different methods forclassifying data (distance) - Build a classification step by step - Practical cases of ascending hierarchical classification Module4: Chemometry - Practical work on labtop of data analysis and generalities and basisof chemometrics - Unsupervised methods (PCA, clustering, ...) -Pre-treatment methods - Supervised methods of quantification (i.e.PLS)
- Lectures and tutorials in remote (zoom and moodle) - Face to face lectures and tutorials (in Bordeaux, faculty of pharmacy) - Face to face lab work (in Bordeaux, faculty of pharmacy) - 61 hours = 47 contact hours (14 lectures, 15 tutorials, 12 lab work, 6 exams); 14 self-study hours (2h private reading, 2h writing assessment, 6h exam preparation, 4h group work preparation) - face to face teaching: 12h lectures, 12h Tutorials, 2 days practice - Distance-based or blended learning,3 h lectures and 1h tutorials
Online Course Requirement
- Maximum number of students: 30 - Selection procedure: Online application + Interview - Selection criteria: bases in analytical chemistry and statisticsDuration: 14h lectures, 15h tutorials and 12h laptop workLanguage of instruction: EnglishMode of delivery: Face-to-face teaching and distance-based
Site for Inquiry
Please inquire about the courses at the address below.
Contact person: Boutayna Rhourri Frihboutayna.firstname.lastname@example.orgLudivine Ferey (coordinator)email@example.comNoelyne Vague firstname.lastname@example.org