PTI - international

VI. PLC Validation Issues and Activities

• Define PLC
• Basic PLC functions
• Explain system architecture and cabling, signal and device issues
• Review functional specifications
• Ladder Logic Programs
• PLC testing issues

Exercise: Examine Vendor Audit Issues

VII. SCADA Validation Issues and Activities

• Define SCADA
• Basic SCADA functions
• Explain system architecture and relationship to PLCs
• Review functional specifications
• SCADA testing issues

VIII. DCS Validation Issues and Activities

• Define DCS
• Basic DCS functions
• Comparison of DCS to SCADA
• Explain system architecture
• Review functional specifications
• DCS testing issues

IX. Learn from Common Mistakes

• Identify key areas of agency concern
• Review sample 483s
• Analyze common origins of FDA observations
• Analyze traceability and change control

Exercise: Analyze and Respond to FDA Observations

Exercise: Review an Extensive 483 for Issues

X. Revalidate Outdated Systems and Mature Equipment Received form Other Sources

• Decide which legacy systems require validation
• How to validate the legacy system
• Summarize the validation process for PLC, SCADA and DCS system