Course Overview

This course presents the qualification of analytical instruments in
the pharmaceutical industry context with a risk-based approach, and
provides examples of applications on the most used instruments.A
template of qualification report is described and implemented
according to regulation recommendation.

Learning Achievement

Competence

Course prerequisites

- first year of master in pharmacy, chemistry or engineer
- English level: B2 
- Computer with a word processor and internet connection

Grading Philosophy

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  RULES
AND PROTOCOL FOR FAILURES 

- Overall mark ⩾ 10/20  - Module mark ⩾ 7.5/20

Course schedule

MODULE 1: INTRODUCTION TO QUALIFICATION 
- Industrial context  - Overview of the analytical instrument
qualification within a risk-based approach framework (risk assessment,
instrument complexity, criticality, instrument groups)  - Components
of data quality (definition, place of method validation, system
suitability tests, quality controlcheck samples)  - Regulatory
requirements for performance verification - Overview of the
qualification phases (user requirement specifications, 4Q model)  -
Summary/timeline  - Practical remarks and recommendation on the
qualification 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 the
regulatory texts for the qualification  - Know how to recognize the
technical parameters and elements of the qualificationKnow how to
qualify an analytical device (GC, UVVIS, MS, HPLC)  - Know how to
write a qualification procedure  - Know how to write a qualification
report

Course type

- 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

Instructor

Other information

Maximum number of students:30Duration: 11 h: 4 h lectures and tutorials, 7 h practice

Language of instruction: English
Mode of delivery: Distance-based and Blended-learning

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