Quality Assurance technician

Description : This module provides an introduction to biopharmaceuticals, their specific characteristics, the main stages of their development, and the production processes : Upstream Process-USP (cell culture), Downstream Process-DSP (purification), and Fill & Finish (F&F).It is based on the regulatory frameworks governing the development of biopharmaceuticals, such as Good Manufacturing Practices (GMP), ICH guidelines, the requirements of regulatory agencies (EMA, FDA), as well as the key stages of production processes (USP, DSP, Fill & Finish).Digital modalities : Activity 1: eLearning / Activity 2 : eLearningTarget audience :Newcomers (technicians, engineers, researchers, and managers) preparing to take up a position in bioproduction or wishing to update their knowledgeStudents and teachers seeking to discover the pharmaceutical industrial environment and the challenges associated with biopharmaceutical production.Support functions (maintenance, regulatory, Quality, HSE, supply chain, Lean, PMO, data) wishing to better understand the fundamentals of bioproduction professionsEmployees in commercial functions, market access, management or partners (suppliers, subcontractors, consultants, investors) not familiar with bioproduction but wishing to better understand the ecosystem and challenges of bioproductionEvaluation procedure :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules

This module covers the fundamentals of Quality Control (QC) in bioproduction, explaining its essential role in biopharmaceutical manufacturing, the types of tests performed, the documents and methods used, as well as sample and deviation management practices.It is based on Good Manufacturing Practices (GMP), quality documentation management standards, and equipment qualification guidelines. The module incorporates tools and methods such as sampling plans, validated control methods, In-Process Control (IPC) monitoring, sample traceability systems, and quality deviation analysis methods.Digital modalities : Activity 1: eLearning / Activity 2 : eLearning / Activity 3 : eLearningTarget audience :Newcomers (technicians, engineers, researchers, and managers) preparing to take up a position in bioproduction or wishing to update their knowledgeStudents and teachers seeking to discover the pharmaceutical industrial environment and the challenges associated with biopharmaceutical production.Support functions (maintenance, regulatory, Quality, HSE, supply chain, Lean, PMO, data) wishing to better understand the fundamentals of bioproduction professionsEmployees in commercial functions, market access, management or partners (suppliers, subcontractors, consultants, investors) not familiar with bioproduction but wishing to better understand the ecosystem and challenges of bioproductionEvaluation procedure :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules

This module presents the fundamental principles of Good Manufacturing Practices (cGMP) as applied to cell culture (USP) in a controlled environment, detailing the various stages of the USP process and the requirements associated with each step.It is based on cGMP (Current Good Manufacturing Practices) guidelines, best practices in hygiene and equipment preparation, bioreactor-based cell culture techniques (real-time monitoring of critical parameters), harvesting procedures, as well as documentation, traceability, and cross-contamination risk control requirements throughout the process.Digital modalities : Activity 1 :  eLearning / Activity 2 : eLearning  / Activity 3 : eLearning 360° Target audience : Operators, technicians, production managers, continuous improvement and performance managers, engineering managers, maintenance staff, or project managers in the pharmaceutical, chemical, or biotechnology sectors.Collaborators joining or working at the interface of a bioproduction unit. Quality Assurance or Quality Control personnel operating in bioproduction.Students in life sciences, pharmacy, or chemistry, or individuals from academic backgrounds seeking to understand the industrial environment of cell culture.Evaluation procedures : A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one ( 80% of correct answers required).

This module presents the application of Good Manufacturing Practices (GMPs / cGMPs) to purification steps (Downstream Process – DSP), detailing the objectives of quality, purity, and safety, as well as the unit operations involved (clarification, chromatography, diafiltration).It covers chromatography and filtration techniques, in-process controls (IPCs), and is based on cGMP guidelines (FDA, ICH) that govern quality documentation (SOPs, batch records) and deviation management tools.Digital modalities : Activity 1: Serious Game 2D  / Activity 2 :  Serious Game 2D / Activity 3 : eLearning 360°Target audience : Operators, technicians, production managers, continuous improvement and performance managers, engineering managers, maintenance staff, or project managers in the pharmaceutical, chemical, or biotechnology sectors.Collaborators joining or working at the interface of a bioproduction unit.Quality Assurance or Quality Control personnel operating in bioproduction.Students in life sciences, pharmacy, or chemistry, or individuals from academic backgrounds seeking to understand the industrial environment of biomedicine purification.Evaluation procedures :  A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one ( 80% of correct answers required).

Important information: If you choose the accessible version of a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This module presents all the steps involved in starting up an aseptic filling line, from equipment checks and isolator preparation (line clearance, glove integrity testing, decontamination cycle) to setting up the filling process in sterile containers and initiating production.It draws on key tools and procedures such as line clearance, glove integrity testing, vaporized hydrogen peroxide decontamination cycle, environmental monitoring (settle plates, particle counters), batch record traceability, and the reconciliation procedure at the end of production.Digital modalities : Activity 1: Serious Game 3D  / Activity 2: Réalité Virtuelle / Activity 3: Serious Game 3DTarget audience : Newcomers (operators, technicians, engineers, researchers, and managers) preparing to take up a position in Fill & Finish (formulation, aseptic filling, and packaging roles) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academic backgrounds seeking to understand the industrial environment of Fill & Finish.Support functions (maintenance, regulatory affairs, Quality Assurance, Quality Control, HSE, etc.) wishing to better understand the fundamentals of Fill & Finish roles.Evaluation procedures :A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one ( 80% of correct answers required).