Qualification University of Bordeaux
This course presents the qualification of analytical instruments inthe pharmaceutical industry context with a risk-based approach, andprovides examples of applications on the most used instruments.Atemplate of qualification report is described and implementedaccording to regulation recommendation.
- first year of master in pharmacy, chemistry or engineer - English level: B2 - Computer with a word processor and internet connection
MODULE 1: - Quiz on qualification rules15 min25 % weight of overall mark MODULE 2: - Report on the lab work1h3050% weight of overall mark -Interactive exercice online15 min25% weight of overall mark RULESAND PROTOCOL FOR FAILURES - Overall mark ⩾ 10/20 - Module mark ⩾ 7.5/20
MODULE 1: INTRODUCTION TO QUALIFICATION - Industrial context - Overview of the analytical instrumentqualification within a risk-based approach framework (risk assessment,instrument complexity, criticality, instrument groups) - Componentsof data quality (definition, place of method validation, systemsuitability tests, quality controlcheck samples) - Regulatoryrequirements for performance verification - Overview of thequalification phases (user requirement specifications, 4Q model) -Summary/timeline - Practical remarks and recommendation on thequalification process - Example of an HPLC qualification (DQ, IQ,test procedures and acceptance criteria, system suitability testing) MODULE 2: PRACTICE OF QUALIFICATION - Know what an operational qualification is - Identify theregulatory texts for the qualification - Know how to recognize thetechnical parameters and elements of the qualificationKnow how toqualify an analytical device (GC, UVVIS, MS, HPLC) - Know how towrite a qualification procedure - Know how to write a qualificationreport
- Lectures and tutorial in remote (Zoom and Moodle) - Face-to-face tutorial and practice - 11 contact hours (4 lectures, 7 lab work, 2 exam) - 14 self-study hours (4h private reading, 4h writing assessment, 7h group work preparation)
Online Course Requirement
Maximum number of students:30Duration: 11 h: 4 h lectures and tutorials, 7 h practiceLanguage of instruction: EnglishMode of delivery: Distance-based and Blended-learning
Site for Inquiry
Please inquire about the courses at the address below.
Contact person: Boutayna Rhourri Frihboutayna.firstname.lastname@example.orgEric Largyeric.email@example.comNoelyne Vague (secretary)firstname.lastname@example.org