Effective Supplier Management Programs

Topics

• Elements of a Robust Supplier Management Program
  • Quality Agreement template review
  • Standard Operating Procedure (SOP) example
  • Onboarding
  • Initial qualification
  • Development
  • Monitoring / Scorecards
  • Phase-Out
• Review Supplier Management Regulatory Guidance
  • ICH
  • ISO
  • EU
  • FDA
• Review of Risk Analysis Tools and Recent Audit Observations
  • Review recent FDA audit observations applicable to supplier management
  • Review an example FMEA classifying different suppliers by criticality

Who should Attend

• Supply Chain Departments
• Quality Assurance Departments
• Compliance Departments
• Regulatory Affairs Departments
• Contract Manufacturing Organizations (CMOs)
• Operations Departments
• FDB3200
• International Suppliers