FDA Scrutiny of Purchasing/Supplier Controls 2016

Key Topics

• Effectiveness and applicability of these controls for their suppliers, raw materials, components and services using a risk based approach
• Purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016
• Select suppliers based on their capabilities to meet regulatory and manufacturing requirements
• Successful quality plans for incorporating requirements into the quality system
• Establish robust and clear supplier agreements
• Establish procedures and records showing adequate supplier control

Who should Attend

• Regulatory professionals
• Quality professionals
• Purchasing supervisors
• Compliance professionals
• Design engineers
• Manufacturing engineers
• Document control specialists
• Quality engineers