PTI - international

Agenda: Day Two

V. Conduct Internal Audits to Ensure GxP Compliance and Improve Performance

• Compare auditing for effectiveness vs. compliance
• Establish the phases of an internal audit
• Examine the special considerations for auditing different functional areas
• Define audit standards and execute a comprehensive, logical audit
• Define major vs. minor observations
• Evaluate audit findings and deliver an effective audit report

Exercise: Critique a Sample Audit Report

VI. Determine Appropriate Actions Where Non-Compliance is Identified

• Examine common compliance challenges
• Address objectionable observations
• Provide recommendations for corrective and preventive actions (CAPA)
• Identify methods to ensure corrective action follow-up
• Write process deviations and failure reports
• Manage remediations work after an audit

Exercise: Identify Common Causes of OOS Investigations and Brainstorm Possible Solutions

VII. Ensure Effective Management of Change

• Examine the fundamentals of change control
• Define areas to review in a change control program
• Use complaint systems and annual product review to monitor for change

VIII. Use Internal Audits to Prepare for Regulatory Inspections

• Anticipate and prevent potential problems and prepare audit plans
• Develop skills to effectively manage the inspection
• Define which records are required for various inspections
• Analyze the inspection approach
• Establish timelines for inspection preparation
• Examine previous audit reports and all OOS notices since the last audit
• Complete a pre-audit assessment
• Learn how the site prepares throughout the inspection process

Exercise: Review Current FDA 483s and Warning Letters to Recognize Common Trigger Points

IX. Examine FDA Inspection Techniques

• Determine how FDA inspectors conduct inspections
• Identify key points, common observations and comply with FDA expectations
• Examine proven solutions to challenging issues
• Meet the challenges of the FDA's Systems-Based Inspection and quality systems inspection technique
• Assess legal implications of FDA inspections
• Compare U.S. vs. foreign inspections

Interactive Discussion: Do's and Don'ts During an FDA Inspection