Data integrity (EN)
Understand the key principles of Data Integrity and their role in regulated environments. You identify ALCOA++, regulatory expectations, and best practices to ensure reliable and compliant data.
- Biopharmaceutique - procédés et qualité
- Gosselies
- 1 day
- 12 people max.
- Alphacademy
- Entreprise
- Présentiel, Anglais
Before you register
Target audience : Anyone involved in the pharmaceutical or life sciences industry who handles, records, or analyzes data
Prerequisites : Knowledge of the pharmaceutical environment is an asset
Learning objectives
- Identify the ALCOA++ principles and their role in data integrity
- Explain the impact of data integrity on regulatory compliance and patient safety
- Distinguish good and poor data management practices through concrete examples
- Detect data integrity gaps within quality and operational processes
- Apply data management principles in accordance with cGMP, FDA, and EMA regulatory requirements
Training content
- Key concepts and definitions related to data integrity
- Regulatory and quality issues associated with data management
- Role of data integrity in patient safety and regulatory compliance
- ALCOA++ principles and their practical applications
- Requirements related to data traceability, reliability, and accuracy
- Behaviors and practices aligned with regulatory expectations
- Examples of good and poor data management practices
- Detection of data integrity gaps in real-world situations
- Corrective actions adapted to regulatory requirements
- Consolidation of the key concepts covered during the training
- Review of ALCOA++ principles and their application
- Final assessment of learning outcomes
Tarifs et aides financières
612 €
Formation catalogue planifiée chez aptaskil, avec un maximum de 25 % du groupe de participants issus d'une même organisation
Formation catalogue réservée à votre équipe, organisée dans vos locaux ou chez aptaskil selon vos préférences
Formation entièrement construite avec vous, adaptée à vos objectifs, votre contexte et vos besoins opérationnels
Cette formation vous intéresse ?
La formation n'est actuellement pas programmée en inter-entreprise. Si vous souhaitez vous former vous ou vos collaborateurs, notre équipe peut organiser cette formation en intra-entreprise ou l'adapter à vos besoins spécifiques.
