Fill & Finish in cGMPs

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 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 a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This immersive module, delivered in virtual reality, covers the different stages of receiving, inspecting, and handling materials used in the Fill & Finish process. It presents best practices for storage areas (quarantine, ready-to-use, cold rooms, reject area), documentary and physical verification upon receipt, as well as safety precautions when handling dry ice and liquid nitrogen.It is based on receiving procedures in compliance with currentGood Manufacturing Practices (cGMP), management tools such as the ERP (Enterprise Resource Planning) system, physical integrity checks (labeling, leaks, seals), personal protective equipment (PPE), and specific guidelines for handling products stored in dry ice or liquid nitrogen.Digital modalities : Activity 1: Virtual Reality / Activity 2: Virtual Reality / Activity 3: 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 a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.The module details the steps of the bioproduct formulation process, from thawing to sterile filtration. It also covers aspects related to weighing, mixing, and sampling.It is based on the batch record to apply formulation protocols and introduces the principles of in-process controls (IPC) and samples sent to Quality Control (QC). The regulatory requirements of an aseptic environment are also highlighted as prerequisites before start-up.Digital modalities : Activity 1: eLearning  / Activity 2: Serious Game 2D / Activity 3: Serious Game 2DTarget 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 a 3D or virtual reality activity, please contact the support team to manually unlock the rest of the training.This module presents the specific requirements for aseptic filling lines. It covers the environmental conditions to be controlled, the equipment used, as well as the organization and execution of interventions during production (routine, non-routine, unplanned). Particular attention is given to contamination risk management and the importance of the Media Fill Test as a method of aseptic validation.It is based on Good Manufacturing Practices (GMP; EMA Guide 4.2), ISO standards for cleanliness classes (ISO 14644), and ICH Q9 guidelines on quality risk management. It details the tools and methods for controlling air quality (air handling systems, area classification, protective equipment, contamination control techniques such as settle plates, sampling, and particle counters). It also outlines methods for sterilizing components, aseptic connections, and the different types of pumps and needles used.Digital modalities : Activity 1: eLearning   / Activity 2: Virtual Reality / Activity 3: 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).