- Understanding Data Integrity requirements
- Knowing how to organise compliance
- Knowing how to remain proactive with regard to Data Integrity
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, Purchasing, etc.
Acquiring fundamentals/further development
- Introduction and aims of IT system validation
- The pharma, MD, cosmetics, multivigilance context of regulated data integrity
- Definition and terminology, ALCOA and the life cycle of data
- Requirements for IT systems, registrations, discrepancies, and remediation
- Variances, the most common risks corporate regulatory authorities look for
- Data management
Have an awareness of IT Systems.
7-hour classroom attendance