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
Introduction to Data Integrity
- 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
- ALCOA++ principles and their practical applications
- Requirements related to data traceability, reliability, and accuracy
- Behaviors and practices aligned with regulatory expectations
Case Studies and Practical Application
- Examples of good and poor data management practices
- Detection of data integrity gaps in real-world situations
- Corrective actions adapted to regulatory requirements
Review and Assessment of Learning Outcomes
- Consolidation of the key concepts covered during the training
- Review of ALCOA++ principles and their application
- Final assessment of learning outcomes
Fonds de formation du secteur chimie, plastiques et sciences de la vie qui finance les formations des collaborateurs des CP 116 et 207
Fonds de formation du secteur agroalimentaire qui finance les formations des collaborateurs des CP 118 et 220
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.
