PTI - international

VI. Audit the Supplier

• Review the essentials of compliance auditing 
• Plan the audit 
• Perform a pre-audit assessment 
• Examine various audit approaches and issues encountered 
• Determine what to include in the audit report
  • internally
  • externally
• Identify document retention requirements

Exercise: Critique a Sample Audit Report

VII. Ensure Proper Supplier Qualification Documentation

• Examine critical qualification documents
• Identify the frequency of on-going monitoring based on the type of supplier
• Identify the components of effective on-going monitoring reports

VIII. Determine Appropriate Steps to Take When the Supplier Does Not Comply

• Identify the regulatory responsibilities of the sponsor
• Examine common compliance challenges and brainstorm possible responses
• Determine when FDA notification and involvement is required
• Examine de-certification 
  • when is it appropriate
  • what steps must be taken

Exercise: Identify Common Sub-Contracting Pitfalls and Brainstorm Possible Solutions

IX. Ensure the Management of Change

• Examine the fundamentals of change control 
• Define areas to review in a supplier's change control program 
• Assess supplier change control models 
• Evaluate recommended change classification system for suppliers 
• Use complaint systems and Annual Product Review to monitor for change

X. Examine FDA Expectations

• Explain recent FDA inspectional observations 
• Anticipate and avoid common obstacles

Exercise: Construct a Sample Supplier Qualification Procedure