USP (Upstream process) in cGMP

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 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).

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 teaches the expected behaviors in a USP controlled environment in compliance with cGMPs, with a focus on contamination prevention, strict hygiene, and rigorous management of high-risk operations.The module is based on cGMP standards, classifications of controlled areas (ISO / EU Grades A-B-C-D), best practices for handling under a biosafety cabinet (BSC), procedures for managing high-risk situations, as well as cleaning methods, waste disposal, and documentation traceability.Digital modalities : Activity 1 : eLearning   / Activity 2 : Serious Game 2D / Activité 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 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 different types of controls performed during production in a USP environment to ensure the quality, integrity, and compliance of biological products, in accordance with cGMP requirements.It covers the categorization of In Process Controls (IPCs) – in-line, at-line, and off-line – the sampling protocols described in the sampling plan, documentation requirements (batch record), as well as deviation management and the implementation of corrective actions to support continuous process improvement.Digital modalities : Activity 1 : eLearning  / Activity 2 :  Serious Game 2D / Activity 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 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 explores the principles of data integrity within USP processes, in connection with cGMP requirements, and addresses the challenges associated with the increasing digitization of industrial data.It is based on ALCOA+ principles, regulatory requirements for electronic data (21 CFR Part 11), best practices for managing the digital data lifecycle, cybersecurity protocols, as well as case studies on deviations and the correction of anomalies in both handwritten and electronic records.Digital modalities : Activity 1 : eLearning  / Activity 2 : Serious Game 2D  / Activity 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 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).