The Data Integrity & Computer System Validation 3 Day Workshop 2018 covers topics such as:
- Primer on Part 11 and CSV
- What is Data Integrity?
- Why Data integrity issues occur
- Group exercise: Mapping DI to Part 11
- Data Integrity in the Laboratory
- Take back to work - How to implement a DI program
- How to validate Data Integrity
- Group exercise: Develop a Audit Trail design and Audit trail review SOP
- How is Data Integrity audited
The Data Integrity & Computer System Validation 3 Day Workshop 2018 brings together:
- Developers of software for use in Life Sciences industry
- Pharmaceutical industry / Medical device industry / Healthcare industry personnel
- Manufacturing personnel
- Validation service providers, IT service providers
- Regulatory Affairs group, Quality Unit
- Manufacturing Automation system vendors and system integrators
- Clinical Trials sponsors and conductors
