PTI - international

Achieving Regulatory and Business Success

My PTI - international

Login form

Sign Up

Forgot Password?

Search Form

Auditing and Qualifying Suppliers and Vendors

Strategies for Ensuring a Successful Partnership

This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com

Agenda: Day Two

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

Booking Options

This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com

Other Pages

Powered by Janmedia Interactive, Inc.