Validation University of Bordeaux
This course presents the theory and methods of analytical methodvalidation and cleaning validation including process capability,control charts, acceptance sampling, quality engineering, and qualitycontrol concept. The course introduces two approaches of validationmethod: criteria based approach and accuracy profile.
- Hold a first year of master of pharmacy, analytical chemistry orengineer with bases in statistics - English level: B2 - Computer with spreadsheet and internet connection
MODULE 1: - Exercise on excel file on accuracy profile - 2 h - 50% weightof overall markMODULE 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 FORFAILURES - Overall mark > 10/20 - Module mark > 7.5/20
MODULE 1: ANALYTICAL METHOD VALIDATION: - Understand what the validation procedure means - Why and when tovalidate - Identify the regulatory texts that define the validationof analytical methods - Know the analytical method validationparameters - Know the statistical bases to perform validation of ananalytical method - Build a step by step validation method - Knowhow to perform an accuracy profile MODULE 2: CLEANING METHODVALIDATION: - Identify the texts regulating cleaning - Identify the importanceand the obligation to carry out cleaning and its validation in thepharmaceutical industry - Establish the level of cleaning adaptedto the situation - Choose the right cleaning method - Determineand know the sampling methods - Define the surface and number ofsamples - Define the worst case to consider: sample equipment -Establish the appropriate validation criteria - Determine theperiod of validity of the cleaning - Apply the cleaning validationprotocol - Identify all the elements present in the cleaningvalidation report - Production of a validation report
- 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
- 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 andprofessional project Duration: 6 h lectures, 6 h tutorials, 8 h days lab workLanguage of instruction: EnglishMode of delivery: Distance-based or blended-learning
Site for Inquiry
Please inquire about the courses at the address below.
Contact person: Boutayna Rhourri Frihboutayna.email@example.comNoelyne Vague (secretary)firstname.lastname@example.org