Quality engineer

This module introduces the fundamental principles of technology transfer in bioproduction, outlining the key stages, stakeholder roles, and success factors involved in transferring a process from a development site to a manufacturing site.It relies on structuring tools such as GARAMP (Gap Assessment, Risk Assessment and Mitigation Plan), the preparation steps of the receiving unit, validation and comparability principles, as well as a modeling of the overall transfer process, including gap assessment, risk analysis, and the corresponding remediation plan.Digital modalities : Activity 1: eLearning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D / Activity 4: Serious Game 2DTarget audience : Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.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 : Activity 1 is available in three formats: virtual reality, serious game 3D, or an accessible PDF version. You are free to choose whichever option suits your equipment and preferences.This module offers an immersive case study on the industrial transfer of a monoclonal antibody production process, analyzing the gaps between laboratory and manufacturing scales, and the key success factors for large-scale implementation.It is based on the GARAMP methodology (Gap Assessment, Risk Assessment, Mitigation Plan), the analysis of scale-up impacts (raw materials, USP/DSP equipment, critical parameters), the preparation of the manufacturing site, and the verification of outcomes from the initial technical batches.Digital modalities : Activity 1: Virtual Reality / Activity 2: Serious Game 3DTarget audience : Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.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 immerses the learner in the operational management of a bioproduction unit operating under cGMP conditions, integrating quality requirements, Health, Safety and Environment (HSE) constraints, and the practical handling of safety and quality deviations.It is grounded in Good Manufacturing Practices (GMP/cGMPs), HSE principles, problem-solving methodologies (such as the 5M diagram and the 5 Whys method), and covers the complete deviation management process—from identification and criticality assessment, to root cause investigation, and the implementation of Corrective and Preventive Actions (CAPA).Digital modalities : Activity 1: eLearning / Activity 2:  Serious Game 3D / Activity 3: Serious Game 3DTarget audience : Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.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 key principles of data integrity and their applications in bioproduction through concrete, real-life scenarios.It is based on the ALCOA++ principles, as well as the guidelines from the EMA and the FDA (21 CFR Part 11).Digital modalities : Activity 1: eLearning / Activity 2 : Serious Game 2D / Activity 3 : Serious Game 2DTarget 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

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