Data Integrity Training Course

• 1-Day Training Course
• Webinar or Face to Face (F2F) Learning
• Expert Trainer With Data Integrity Implementation Experience in Life Sciences

This 1-Day interactive course aims to provide the knowledge and skills required by employees to understand the importance of Data Integrity in the Life Science industry and to be able to implement practices that maintain the accuracy, consistency, and reliability of data.

The ultimate learning goal for participants is to be able to implement and maintain robust Data Integrity practices in compliance with regulatory requirements, ensuring the reliability and trustworthiness of data within their organisation.

Learning Outcomes

In this course employees will learn about essential concepts and practices to equip employees 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.

Target Audience

This course will be of great value to anyone currently working in the Life Science Industry, or any other highly regulated and proceduralised industry that is subject to Data Integrity regulatory requirements.

Examination

The course is concluded with an optional examination.