Quality engineer

Description : This module provides an introduction to biopharmaceuticals, their specific characteristics, the main stages of their development, and the production processes used in bioproduction.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

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 explores performance and compliance levers in bioproduction through Lean approaches, controlled maintenance, and Industry 4.0 tools, with a constant focus on quality and data integrity.It is based on the principles of the Lean House and draws on tools such as the 5S method, the PDCA cycle, Kaizen, Kanban, and Six Sigma approaches.Digital modalities : Activity 1: eLearning / Activity 2 : Serious Game 3D / 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 key stages of the Fill & Finish process, including storage, formulation, filling, visual inspection, labeling, and packaging. It also introduces patient risks and their management, and details dosage forms as well as the stability of biopharmaceutical products.The module addresses patient risk management and the constraints related to the stability of biopharmaceuticals. It adopts a descriptive approach to the different product types (proteins, mRNA, cells), highlighting the differences with chemically derived pharmaceutical products, as well as the factors influencing their stability during formulation operations.Digital modalities : Activity 1: eLearning   / Activity 2: eLearning Target 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).

Important information: If you choose the accessible version of the 3D activity, please contact the support team to manually unlock the rest of the training.This module explores the logistical challenges related to the transport of bioproducts throughout their life cycle, from production to patient delivery. It covers the specificities of logistics flows (domestic and international), transport modes, regulatory constraints, associated risks, and the responsibilities of the various stakeholders in the supply chain. A practical case study is also included to simulate the secure organization of a shipment. It is based on Good Distribution Practices (GDP), key international transport regulations (CMR – Convention on the Contract for the International Carriage of Goods by Road, Brussels Convention, Montreal Protocol, CIM – International Convention concerning the Carriage of Goods by Rail), INCOTERMS (International Commercial Terms), risk management tools (risk matrix, business continuity plan), as well as best practices for shipment security and customs compliance. Digital modalities: Activity 1 : eLearning / Activity 2 : eLearning / Activity 3 : eLearning / Activity 4 : Serious Game 3DTarget audience: Employees integrating or working in production sites, distribution centers, or in the transport and storage of pharmaceutical products and bioproducts (logistics, customs operations, export managers, customer service, supply chain, freight forwarders) wishing to acquire the fundamentals of logistics applied to bioproducts. Support functions (Quality Assurance, Quality Control, HSE) or partners (suppliers, subcontractors, consultants, CMOs) wishing to better understand the challenges of logistics applied to bioproducts. Evaluation procedure: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).