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. View the full overview here.
Who will the course benefit?
This 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.
- Background and introduction to Data Integrity
- Industry Regulations and Guidance
- 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
- 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
- Implications for New projects
- Review of example warning letters and citations
Click here for more information.
MediWales members discount:
The following discount applies to delegates from the same business/organisation attending Data Integrity Training Course on 23/11/17 in Cardiff:
10% off first delegate
15% off second delegate
20% off third delegate
Get the booking form here.