PTI - international

VIII. Explore How Study Data are Examined Statistically

• Describe Good Automated Manufacturing Practices (GAMP®)
• Identify the five categories of software
• Evaluate software validation methodologies
• Examine ISO and IEEE standards

Exercise: Analyze a Sample Data Set

IX. Overcome Common Documentation Pitfalls

• Identify software requirements and design documentation
• Develop computer and software validation protocols
• Ensure traceability and archive efficiently
• Develop compliant SOPs
• Write instructions for training users
• Use matrix documents for testing
• Write an effective summary report

Discussion: Software Testing

X. Ensure Your Legacy Systems are FDA Compliant

• Determine what systems are legacy systems
• Perform retrospective validation
• Integrate with newer systems

XI. Validate Off-the-Shelf (OTS) Software

• Identify FDA expectations
• Develop validation and verification protocol for OTS software
• Validate legacy and OTS systems

Exercise: Essential Characteristics for CSV Documents and Teams

XII. Audit Software Vendors to Ensure Compliance

• Identify FDA expectations
• Develop validation and verification protocol for OTS software
• Validate legacy and OTS systems

Exercise: Essential Characteristics for CSV Documents and Teams

XIII. Analyze Current FDA Expectations and Inspection Trends

• Clarify the FDA's interpretation of the scope and application of 21 CFR Part 11
• Identify the latest FDA trigger points
• Avoid common deficiencies

Discussion: Emerging Industry Standards

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