Course Overview

This course presents the theory and methods of analytical method
validation and cleaning validation including process capability,
control charts, acceptance sampling, quality engineering, and quality
control concept. The course introduces two approaches of validation
method: criteria based approach and accuracy profile.

Learning Achievement

Competence

Course prerequisites

-  Hold a first year of master of pharmacy, analytical chemistry or
engineer with bases in statistics
- English level: B2 
- Computer with spreadsheet and internet connection

Grading Philosophy

MODULE 1: 
- Exercise on excel file on accuracy profile  - 2 h  - 50% weight
of overall mark

MODULE 2: 

- Quiz Theoretical aspects on cleaning validation  -  15 min  -
 12,5% weight of overall mark  - Interactive online exercise:
Serious game on the cleaning process (Moodle)  -  15 min  -
 12,5% weight of overall mark  - Cleaning validation report  -
 30 min  - 25% weight of overall mark  RULES AND PROTOCOL FOR
FAILURES 

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

Course schedule

MODULE 1: ANALYTICAL METHOD VALIDATION: 
- Understand what the validation procedure means  - Why and when to
validate  - Identify the regulatory texts that define the validation
of analytical methods  - Know the analytical method validation
parameters  - Know the statistical bases to perform validation of an
analytical method - Build a step by step validation method  - Know
how to perform an accuracy profile  MODULE 2: CLEANING METHOD
VALIDATION: 

- Identify the texts regulating cleaning  - Identify the importance
and the obligation to carry out cleaning and its validation in the
pharmaceutical industry  - Establish the level of cleaning adapted
to the situation  - Choose the right cleaning method  - Determine
and know the sampling methods  - Define the surface and number of
samples  - Define the worst case to consider: sample equipment  -
Establish the appropriate validation criteria  - Determine the
period of validity of the cleaning  - Apply the cleaning validation
protocol  - Identify all the elements present in the cleaning
validation report  - Production of a validation report

Course type

- Lectures and tutorial in remote (Zoom and Moodle)  - Face-to-face lab work (in Bordeaux, faculty of pharmacy) - 21 contact hours (6h lectures, 6h tutorials, 6h lab work, 3h exam)  - 21 self-study hours (4 private reading, 4 writing assessment, 6h exam preparation, 7 group work preparation) 

Online Course Requirement

Instructor

Other information

- Maximum number of students: 30 
- Selection procedure: online application + interview 
- Selection criteria: bases in analytical chemistry and statistics,
the adequacy of the initial training, professional experience and
professional project 

Duration: 6 h lectures, 6 h tutorials, 8 h days lab work

Language of instruction: English
Mode of delivery: Distance-based or blended-learning

Site for Inquiry