This Data Integrity training course is aimed principally at Management and Supervisory roles who need a detailed understanding of the Data Integrity requirements and regulatory expectations. The course will provide the delegates with the understanding required to enable implementation of required Data Integrity governance systems, methodologies and programmes.
Course overview:
Delegates will learn about Data Integrity threats and issues posed within paper and electronic systems and how to comply with regulatory requirements. Delegates will leave the course with a clear understanding of the current expectations of EU Inspectors (such as the UK’s MHRA) and the FDA.
We now have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic - visit our website for more details
Course contents:
Background and introduction to Data Integrity
Industry Regulations and Guidance
Data integrity applied to paper-based and computer-based systems
Introduction to the Data Life cycle model:
Stage 1 – Data Collection
Stage 2 – Data Processing
Stage 3 – Data Review
Stage 4 – Data Reporting
Stage 5 – Data Archiving
Data Archiving and ALCOA principles
Risk identification, audit challenge and threat management
The Governance System – what do you need?
Outsourced GMP activities – expectations and implications
Identification of audit challenges and additional governance
