DSP (Downstream process) 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 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).

Information importante : Si vous choisissez la version accessible d'une activité 3D ou en réalité virtuelle, veuillez contacter le service d’assistance pour débloquer manuellement la suite de la formation.This module presents the sources of viral contamination, the viral clearance steps integrated into the DSP (purification) process, and the principles of viral validation studies.It details the mechanisms of virus inactivation and removal, the three pillars of viral safety, as well as the regulatory requirements governing validation studies.The content is based on ICH Q5A guidelines, cGMP practices, raw material risk assessment, and the methodology of conducting viral validation studies. Modalités digitales : Activité 1: Serious Game 2D / Activité 2: Serious Game 3D / Activité 3: Serious Game 2DTarget 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 : Une courte évaluation à la fin du module pour confirmer ce que vous avez appris et accéder au module suivant (80% de bonnes réponses requises).

This module teaches the expected behaviors in a controlled DSP environment compliant with cGMP standards, with a focus on contamination prevention, strict hygiene, and the proper handling of high-risk operations.The module is based on cGMP standards, classifications of controlled environments (ISO / EU A-B-C-D), class A equipment (biosafety cabinets, laminar flow hoods), quality procedures (gowning, cleaning, sampling), and deviation management tools such as CAPA and documentation protocols.Digital modalities : Activity 1 : Serious Game 2D  / Activity 2 :  Serious Game 2D / Activity 3 : Serious Game 3DTarget 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 cleaning methods for equipment used in Downstream Processing (DSP), highlighting their essential role in preventing contamination and ensuring compliance with quality standards in bioproduction.It is based on cGMP guidelines, in-place cleaning (CIP) and sanitization (SaIP) techniques, validation strategies (3 consecutive batches), analytical criteria (endotoxins, pH, conductivity), as well as quality documentation (batch records, sampling procedures) and deviation investigation practices.Digital modalities : Activity 1:  Serious Game 2D / Activity 2 :  Serious Game 2D / Activity 3 : Serious Game 3DTarget audience : Operators, technicians, production managers, continuous improvement and performance managers, engineering managers, maintenance staff, or project managers in the pharmaceutical, chemical, or biotechnology sectorsCollaborators 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).