Data Integrity in Healthcare industry: all steps up to product batch release

This module introduces the fundamental concepts related to data integrity in the pharmaceutical industry, emphasizing its regulatory importance, the causes of errors, the role of metadata, and the evolution of requirements in the digital era.It covers the types of data encountered in the health industry (paper-based, electronic, hybrid), the data lifecycle, ALCOA+ principles, and key roles in implementing data integrity in accordance with GxP requirements.Digital modalities: Activity 1 : eLearning / Activity 2 : eLearning/ Activity 3 : Serious Game 2D Target audience : Employees in the pharmaceutical, chemical, or biotechnology industries preparing to take up a position in Quality Assurance (QA) (operational, systems, or validation) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academia wishing to understand quality-related challenges in the industrial environment.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)

This module explores practical levers for implementing data integrity within organizations: governance, roles, methodology, risk analysis, and compliance monitoring.It is based on the application of the nine ALCOA+ principles, governance components (leadership, roles and responsibilities), the data integrity risk assessment (DIRA) methodology, remediation measures, as well as indicators and monitoring tools to ensure operational compliance.Digital modalities:  Activity 1 : eLearning / Activity 2 : Serious Game 2D / Activity 3 : Serious Game 2DTarget audience : Employees in the pharmaceutical, chemical, or biotechnology industries preparing to take up a position in Quality Assurance (QA) (operational, systems, or validation) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academia wishing to understand quality-related challenges in the industrial environment.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 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 offers a comprehensive exploration of the computerized system validation process in a GxP environment, structured around four key stages: validation fundamentals, structuring of the V-cycle, verification phase, and long-term maintenance of the validated state.It is based on the requirements and tools associated with computerized system validation, including the scope and organization of validation through the Validation Master Plan (VMP), the structuring of the V-cycle with its key deliverables (user requirements specifications, functional specifications, traceability matrix, functional risk assessment). It also covers the qualification steps (IQ, OQ, PQ) in both test and production environments, as well as measures to maintain the validated state such as periodic review, incident management, audit trail review, and data integrity risk assessment (DIRA).Digital modalities: Activity 1: eLearning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D / Activity 4 : Serious Game 3DTarget audience : Employees in the pharmaceutical, chemical, or biotechnology industries preparing to take up a position in Quality Assurance (QA) (operational, systems, or validation) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academia wishing to understand quality-related challenges in the industrial environment.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 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 places participants in regulatory inspection scenarios to analyze real-life cases of data integrity deviations across various departments of a pharmaceutical organization.It is based on realistic inspection situations (Audit Trail review, user access management, uncontrolled paper forms, data entry errors, line clearance), the types of observations encountered (critical, major, minor), expected behaviors during an inspection, and the documentation requirements to respond appropriately to findings.Digital modalities : Activity 1 Part 1: eLearning / Activity 1 Part 2: Serious Game 3D / Activity 2: Serious Game 3D / Activity 3: Serious Game 3DTarget audience : Employees in the pharmaceutical, chemical, or biotechnology industries preparing to take up a position in Quality Assurance (QA) (operational, systems, or validation) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academia wishing to understand quality-related challenges in the industrial environment.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 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 addresses the application of data integrity principles to the batch release process for biopharmaceuticals. It is structured around three key areas: a brief reminder of the drug development, the connection between data and batch release, and the analysis of real-life situations that may compromise batch compliance.It is based on regulatory requirements for batch release (EU GMP Annex 16), the role of data in decision-making, deviation scenarios (data entry errors, data loss, discrepancies in the batch record, etc.), and best practices for verification and documentation needed to ensure compliant release.Digital modalities : Activity 1: eLearning / Activity 2: Serious Game 2D  / Activity 3: Serious Game 3DTarget audience : Employees in the pharmaceutical, chemical, or biotechnology industries preparing to take up a position in Quality Assurance (QA) (operational, systems, or validation) or wishing to refresh their knowledge.Students in life sciences, pharmacy, or chemistry, or individuals from academia wishing to understand quality-related challenges in the industrial environment.Evaluation procedures : Evaluation at the end of each module to be able to access the next module ( 80% of correct answers required)