>
Quality Control technician
Quality analyses in bioproduction: microbiological, physicochemical, immunological, and molecular methods, in-process controls, and analytical validation in a cGMP environment.
CURRICULUM
Goals
In summary
Prerequisites
This curriculum is intended for entry-level technical staff or individuals undergoing a career change. Participants should have:
- A high school diploma to two-year post-secondary level (Bac to Bac+2) in science (biotechnology, biochemistry, microbiology, pharmacy)
- or initial experience in a control laboratory or in a regulated production environment
- Basic knowledge of analytical techniques and laboratory hygiene and safety rules
Course modules
1 day
Quality Control technician
P1M5 Data Quality and Integrity in Bioproduction: Principles and practical cases (about 2 hours)
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
P1M1 Discovering biopharmaceuticals: key development stages, regulatory framework, and manufacturing processes (about 1 hour)
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
P1M2 Immersion in a cleanroom: preventing contamination and adopting best practices (about 2 hours)
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 covers the characteristics of cleanrooms, the associated contamination risks, and the expected gowning and behavioral practices in production environments.It is based on Good Manufacturing Practices (GMP), ISO standards, principles for controlling the production environment (air classes, airflow, biosafety levels, gowning), as well as on control equipment (laminar flow systems, filters...).Digital modalities : Activity 1: eLearning / Activity 2 : eLearning / Activity 3 : eLearning / Activity 4 : Virtual RealityTarget 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
P5M1 Overview of Quality Control (about 2 hours)
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
P4M2 DSP Process in cGMPs (about 3 hours)
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).
P1M5 Data Quality and Integrity in Bioproduction: Principles and practical cases (about 2 hours)
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
P1M1 Discovering biopharmaceuticals: key development stages, regulatory framework, and manufacturing processes (about 1 hour)
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
P1M2 Immersion in a cleanroom: preventing contamination and adopting best practices (about 2 hours)
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 covers the characteristics of cleanrooms, the associated contamination risks, and the expected gowning and behavioral practices in production environments.It is based on Good Manufacturing Practices (GMP), ISO standards, principles for controlling the production environment (air classes, airflow, biosafety levels, gowning), as well as on control equipment (laminar flow systems, filters...).Digital modalities : Activity 1: eLearning / Activity 2 : eLearning / Activity 3 : eLearning / Activity 4 : Virtual RealityTarget 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
P5M1 Overview of Quality Control (about 2 hours)
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
P4M2 DSP Process in cGMPs (about 3 hours)
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).
P4M6 In-Process Controls (IPCs) for DSP in cGMPs (about 2 hours)
This module presents In-Process Controls (IPCs) applied to the purification steps (Downstream Process – DSP) in a cGMP environment, highlighting their role in monitoring critical process parameters, managing contamination risks, and ensuring product quality.It draws on cGMP and ICH guidelines, analytical methods used for IPCs (pH measurement, conductivity, CE-SDS, cIEF, HPLC-SEC, qPCR, ELISA, LAL), sampling practices both in-zone and off-zone, the PAT initiative for in-line monitoring, as well as the concept of Critical Quality Attributes (CQAs) to ensure product quality throughout the processDigital 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 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).
P2M2 Presentation of cGMP and USP industrial environment (about 2 hours)
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).
P2M4 In-Process Controls (IPCs) for USP in cGMP (about 2 hours)
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).
P5M2a Focus on Microbiology (about 2 hours)
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 potential sources of microbiological contamination, methods of prevention and detection, as well as the lifecycle of microbiological samples from their collection to their analysis in the laboratory. It provides the knowledge needed to identify and control contaminants in order to ensure the safety and quality of pharmaceutical products.The module lists and describes the different categories of contaminating microorganisms, their biological characteristics, and their impacts on processes and biopharmaceuticals. Potential sources of contamination—such as raw materials, air, surfaces, personnel, and equipment—are presented, along with the associated routine microbiological tests used to measure bioburden, sterility, and the detection of mycoplasma and endotoxins. Environmental monitoring methods (air, water, surfaces, personnel) in accordance with EU GMP Annex 1 are explained, as well as the references and standards applicable to biocontamination control (GMP, ISO 14644, NF EN 17141).Digital modalities: Activity 1: eLearning / Activity 2: eLearning / Activity 3: Virtual RealityTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P5M2b Focus on Physico-chemistry and Immunology (about 2 hours)
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 covers the physicochemical and immunological analyses necessary to ensure the quality of therapeutic proteins. It introduces the sources of impurities, their potential impacts on products and patients, and the methods of detecting and quantifying impurities. Practical case studies will provide opportunities to apply the knowledge acquired.It is based on the five fundamental analytical pillars applied to therapeutic proteins (identity, purity, impurities, activity, quantity), the methods associated with each pillar (HP-SEC, cIEF, etc.), techniques for detecting and quantifying impurities at different stages of production (mass spectrometry, liquid chromatography, etc.), as well as best practices for controlling raw materials and starting materials, in connection with contamination prevention and traceability in a GMP environment.Digital modalities: Activity 1: eLearning / Activity 2: eLearning / Activity 3: Virtual RealityTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P5M2c Focus on viral safety and molecular biology tests (about 2 hours)
This module provides an in-depth understanding of the complementary approaches required to ensure viral safety of bioproducts. It introduces molecular biology methods, material selection, viral testing, and viral clearance steps. It is based on the three pillars of viral safety (raw material selection, virological controls, and viral clearance steps), the criteria for selecting raw materials based on their origin and risk profile, virological testing conducted at various stages of the process, detection methods (PCR and RT-PCR), as well as the mechanisms of viral removal and inactivation, primarily applicable to recombinant products.Digital modalities: Activity 1: eLearning / Activity 2: eLearning / Activity 3: Serious Game 2DTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P5M3a Applicative module: microbiological tests (about 2 hours)
This module covers sampling processes in production areas, quality control laboratory operations, and the analysis of unexpected results and deviations. It introduces best practices to ensure sample quality, laboratory testing methods, and approaches for managing deviations and implementing effective corrective and preventive actions (CAPA).It is based on the Contamination Control Strategy (CCS), microbiological controls associated with key stages of the manufacturing process (sterility tests, bioburden, endotoxins), simulated aseptic filling procedures (Media Fill Test), environmental monitoring plans (surface, air, personnel), identity and purity tests of bacterial strains, as well as examples of corrective actions in response to contaminant detection.Digital modalities: Activity 1: eLearning / Activity 2: eLearning / Activity 3: Serious Game 2DTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P5M3b Applicative module: physicochemical test and immunoassay (about 2 hours)
This module covers the physicochemical tests required for quality control of therapeutic proteins and cell therapies. It also addresses the management and storage of reference and retention samples, thereby ensuring product safety and efficacy. It helps learners develop practical skills to ensure compliance with regulatory standards.It is based on analytical techniques commonly used for the quality control of therapeutic proteins (HP-SEC, cIEF, CE-SDS), the analysis of critical parameters in cell therapy using flow cytometry, safety and efficacy tests applied to the drug substance (ELISA, Q-PCR, NGS), as well as best practices for the management and storage of reference samples.Digital modalities: Activity 1: eLearning / Activity 2: eLearning / Activity 3: Serious Game 2DTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P5M3c Applicative module: viral safety and molecular biology tests (about 2 hours)
This viral safety module covers manufacturing controls and in-process controls (IPC) for recombinant bioproducts and vaccines. It also addresses sample management and the manufacturer's responsibilities for test quality. It helps develop skills to apply testing strategies and manage samples throughout the production process.It is based on the release tests required for an inactivated viral vaccine, the regulatory requirements for marketing authorization (dual control by the manufacturer and the authority), sample management procedures (traceability, sampling conditions, protocol compliance), as well as the verification of viral inactivation results according to specified acceptance criteria.Digital modalities: Activity 1: eLearning / Activity 2: eLearning / Activity 3: eLearningTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P5M6 Analytical methods: use cases (about 1 hour)
This module offers an immersive scenario centered around a health authority audit, providing a structured exploration of all analytical practices in Quality Control (QC). The audit unfolds in three stages: inspection of sampling in production areas, review of laboratory analyses (microbiology, virology, raw materials), and investigation of unexpected results and quality deviations.It is based on good sampling practices in production areas (traceability, documentation), analytical methods used in virology, microbiology, and raw material laboratories (ELISA, bioburden testing, etc.), deviation management tools (OOS, OOT, CAPA), and the quality investigation approach to ensure batch release within a GMP framework.Digital modalities: Activity 1: Serious Game 2D / Activity 2: Serious Game 2D/ Activity 3 : Serious Game 2DTarget audience : Employees integrating or working in interface with a bioproduction or Quality Control (QC) unit who wishto acquire the fundamentals of QC methods and challenges applied to biopharmaceuticals.Students in life sciences, analysis and control, pharmacy, or chemistry, as well as individuals from academia seeking to understand the industrial environment of biopharmaceutical QC.Employees already specialized (e.g., microbiology, viral safety, physicochemical or immunological testing) who wish to broaden their skills into other areas of QC.Partners (suppliers, service providers, subcontractors) operating in bioproduction or QC.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)
P10M1 Transportation and logistics management for bioproducts (about 2 hours)
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).
P3M2 Introduction to Fill & Finish (about 1 hour)
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).
Cookies
By continuing to browse this site, you agree to the use of cookies to optimize your experience and offer you content tailored to your needs. You may object to this use of cookies at any time.
By continuing to browse this site, you agree to the use of cookies to optimize your experience and offer you content tailored to your needs. You may object to this use of cookies at any time.
You can choose what you authorize
Only necessary cookies
Performance cookies
Feature cookies
Personnalisation cookies
Ads cookies
