Quality Control of finished product University of Bordeaux
This course will present the theory and methods of analytical methodused for quality control of finished product in pharmaceuticalindustry with a focus on falsified product detection.
- Hold a bachelor or master of pharmacy or analytical chemistry withknowledge on pharmaceuticals - English level: B2 - Computer with excel application and internet connection
Module 1 &2: - Quizzes - 1h - 25 % weight of overall mark Module 3&4: - Written exam: Exercises on sample preparation, analysis, counterfeitdetection - 1h - 50% weight of overall mark Module lab work: - Report on the lab work - 1h - 25% weight of overall mark RULES AND PROTOCOL FOR FAILURES - Overall mark ⩾ 10/20 - Module mark ⩾ 7,5/20
Module 1: Introduction to quality control: - Regulation texts that define the quality of medicines - Qualitycontrol and quality assurance - Raw material and API - Finishedproducts - Packaging (extractible and leachable) - Quality riskmanagement, Quality by Design and quality Control Module 2: Samplingand sample preparation: - Sampling - Sample preparation: method of extraction, solubilityand stability Module 3: Analytical techniques for quality control offinished product: - Gas Chromatography - Liquid Chromatography Module 4: Falsifiedproduct control: - Definition - Methods and techniques for counterfeit productsdetection - Examples
- Lectures and tutorial in remote (zoom and moodle) - Face to face lectures - Face to face lab work (in Bordeaux, faculty of pharmacy) - 75 hours= 41 contact hours (18 lectures, 9 tutorials, 14 lab work, 6 exam); 34 hours self-study (10private reading,8 writing assessment, 6 exam preparation, 10 group work preparation)
Online Course Requirement
- Maximum number of students: 30 - Selection procedure is stated: Online application + Interview - Selection criteria: bases in analytical chemistry and statisticsDuration: 41h: 18 h lectures and, 9h Tutorials, 2 days lab 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.orgNoelyne Vague (secretary)email@example.com