Topics
- Learning from recent FDA 483`s and warning letters
- US FDA and EU requirements and enforcement practices
- Eight fundamental steps for computer system validation
- Selecting the right validation model: qualification vs. verification
- Justification and documentation of risk levels
- Structure and example of a validation plan
- Examples for requirement and functional specifications?
- Example qualification document for suppliers of commercial systems
- OQ test protocols: development, execution, approval - examples
- Example for IQ protocols
- Validation of existing systems
- Documentation of ongoing performance
- Step-by-step case studies from laboratories and manufacturing for easy implementation
- Structure and example of a validation report
Who should Attend
QA Managers and Personnel, IT Managers and System Administrators, Validation Specialists, QC and Lab Managers, Training Departments, Regulatory Affairs, Consultants and Documentation Department.
