Data Integrity GxP Training Course Overview

In this course employees will learn about essential concepts and practices to equip them with the skills and knowledge to help assure Data has Integrity.

Understand Core Data Integrity Principles:

• Understand the regulatory requirements and guidance on Data Integrity.
• Be able to interpret relevant regulations and guidelines, including EU GMP Annex 11, EU GMP Chapter 4, and FDA 21 CFR Part 11.
• Define Data Integrity and its significance in the pharmaceutical and healthcare industries.
• Explain the core principles of ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
• Analyse real-world case studies of electronic and paper-based Data Integrity failures and their impact on organisations.
  

Learn how to manage the Data Integrity Lifecycle:

• Identify the stages of the Data Integrity lifecycle, from creation to archiving and disposal.
• Implement best practices for data management at each stage of the lifecycle.
• Assess risks to Data Integrity within organisational processes and systems.
• Develop and implement risk mitigation strategies to protect Data Integrity.
• Explain the purpose and importance of audit trails in ensuring Data Integrity.
• Conduct effective audit trail reviews and identify potential Data Integrity issues.
• Understand the basic validation requirements for computerised systems used in data management.
• Ensure that computerised systems are compliant with regulatory standards and guidance.
• Identify and report Data Integrity breaches and discrepancies.
• Implement Corrective and Preventive Actions (CAPA) to address Data Integrity issues.
• Establish governance structures and responsibilities for Data Integrity.
• Ensure continuous oversight and review of Data Integrity practices within the organisation.

• Regulatory Compliance: Learn about global regulatory guidelines, such as those from the FDA, EMA, and MHRA, that emphasize the importance of Data Integrity in ensuring reliable and accurate records. This helps ensure compliance with industry standards and avoids penalties.
• Audit Preparedness: Training helps organisations prepare for inspections and audits by ensuring data is traceable, secure, and complete, with clear documentation practices in place.
• Operational Efficiency: By learning how to establish systems and workflows that promote Data Integrity, organisations can improve efficiency and reduce the need for rework, data correction, or compliance-related delays.
• Enhanced Cybersecurity: Gain awareness of the link between Data Integrity and cybersecurity, learning how to protect data from unauthorised access, manipulation, or breaches.
• Cross-Industry Application: The principles of Data Integrity apply across various sectors, including pharmaceuticals, manufacturing, finance, and IT, making this training valuable for professionals in diverse industries.
• Promotes Quality Culture: Data integrity training fosters a culture of accountability and quality, where employees are more aware of the critical nature of data accuracy and transparency in daily operations.
• Career Advancement: Acquiring Data Integrity skills can enhance your professional qualifications and open up career opportunities in quality assurance, regulatory affairs, and compliance roles.