Supplier Management in FDA- and ISO-regulated Industry 2017

Topics

• Supplier Assessment
  • Review of ISO requirements
  • Review of FDA requirements
  • Recommended Practices
  • Case Study: A Hypothetical Supplier Assessment
  • Use of Risk Assessment
  • Documentation requirements
  • Common Pitfalls
• Supplier Selection
  • Review of ISO requirements
  • Review of FDA requirements
  • Defining critical suppliers
  • Types of suppliers that must be qualified
  • Recommended Practices
  • Outsourced processes
  • Use of Risk Assessment
  • Documentation requirements
  • Common Pitfalls
  • The Quality Agreement
• Workshop: Review of Supplier Responses: Acceptable or UNacceptable?
• Supplier Nonconformance
  • Supplier Corrective Action Requests
  • Types of supplier nonconformances

Who should Attend

Attendees from:

• Buyers
• Supply chain management
• CAPA Coordinators
• Purchasing management
• QA management
• Regulatory management
• Internal auditors
• Executive management