PTI - international

V. Examine Electronic Data Management and 21 CFR Part 11 Compliance

• Interpret 21 CFR Part 11 requirements relating to electronic records and documentation
• Identify electronic signature needs
• Examine EU regulations relating to electronic records
• Outline EDMS tools and functionality
• Analyze common computer systems managed by EDM systems

Exercise: Address Obstacles and Common Deficiencies

VI. Examine Documentation Monitoring and Alterations

• Describe the basic elements of change control
• Address the five major deficiencies associated with change control:
  • No procedure
  • Inadequate procedure
  • Procedures not followed
  • Inadequate documentation/evaluation
  • Poor documentation management
• Prepare for a documentation audit
• Improve ability to review and audit documents

Exercise: Case Study - Define Deficiencies of Change Control and Identify Areas for Improvement

VII. Examine Amendments and Respond to Deviations

• Describe planned and unplanned deviations
• Examine techniques for capturing amendments and deviations
• Analyze objectivity vs. subjectivity in formulating conclusions
• Devise methods for safeguarding accuracy of review practices
• Determine the root cause of non-compliance
• Prepare recommendations for corrective actions
• Implement timeframes and secure sufficient corrective action plans

VIII. Execute Successful Audits and Improve Audit Report Writing Practices

• Identify key benefits of successful audits
• Describe audit phases and different types of audit reports
• Assess the impact of what is stated in the exit interview and how to document that in the audit report
• Write reports that are value-added and important to yield corrective action(s)
• Conduct audit follow-up of corrective procedures to yield effective audit close-out

Exercise: Review a Sample Audit Report

IX. Avoid Common Barriers to Success

• Outline recent documentation related issues
• Identify current FDA trigger points - hot topics
• Determine where to go for more information - helpful references

Exercise: Examine Common Pitfalls and Identify Proven Solutions