PTI - international

Agenda: Day Two

VI. Master Documentation and Validation

• Address paper versus electronic documentation procedures
• Utilitze documentatioin to support quality designs, plans and procedures
• Manage change control activities
• Perform validation activities in compliance with the quality systems approach
• Develop an effective validation master plan and supporting documentation

Exercise: Identify Best Practices in Process Validation Documentation

VII. Maximize Evaluation Methods

• Detect deviations and nonconformitites and address discrepancies through investigation activities
• Manage data and evidence gathered from compliants, measurements, deviations, etc.
• Track trends and conduct effective investigations of quality data
• Implement effective corrective and preventive action (CAPA) procedures

Exercise: Complete an Investigation Using Data Trending Analysis

VIII. Demonstrate Your Audit Procedures Address Quality Systems Compliance

• Apply risk assessment techniques to your audit procedures
• Execute audits that focus on critical quality issues
• Understand the importance of a timely audit schedule
• Analyze the Quality Systems Inspection Technique (QSIT) for medical device as a learning tool

Exercise: Case Study - Learning from Medical Device Quality Audits

IX. Evaluate Process Analytical Technology (PAT) as a Quality Measurement Tool

• Understand FDA's recommendations on implementing PAT
• Define PAT capabilities and limitations within the manufacturing setting
• Review the impact of PAT as a process control method

Exercise: Case Study - Applying PAT

X. Identify Current FDA Inspection Trends

• Analyze current FDA interpretation of the quality systems guidance
• Review recent 483s and warning letters
• Apply best practices to prepare for FDA inspections
• Review key elements from training

Exercise: Prepare for an FDA Inspection

Exercise: Question and Answer Session