Computer System Validation: Step-by-Step - Webinar by GlobalCOmpliancePanel

• US FDA and EU requirements and enforcement practices
• Learning from recent FDA 483's and warning letters
• Selecting the right validation model: qualification vs. verification
• Eight fundamental steps for computer system validation
• Structure and example of a validation plan
• Justification and documentation of risk levels
• Example qualification document for suppliers of commercial systems
• Examples for requirement and functional specifications?
• Example for IQ protocols
• OQ test protocols: development, execution, approval - examples
• Documentation of ongoing performance
• Validation of existing systems
• Structure and example of a validation report
• Step-by-step case studies from laboratories and manufacturing for easy implementation

For easy implementation, attendees will receive:

• SOPs: Validation of Commercial Off-the-Shelf Computer Systems
• Checklist: Using computers in FDA regulated environments
• Validation templates and examples

Who will benefit:

• IT managers and system administrators
• QA managers and personnel
• QC and Lab managers
• Validation specialists
• Regulatory affairs
• Training departments
• Documentation department
• Consultants