Cost-Effective Computer System Validation: Step-by-Step 2012

Key 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.