Changing Supplier Controls Requirements 2015

Topics

• Avoid Complacency from Past Good FDA / ISO audits
• The Globalization of the Supply Chain and What That Means
• Mandated Supplier Controls; Change Controls
• Supplier Ranking Models
• The Tiered Risk-Based Audit Approach
• COAs / COCs
• Entropy; Maintain the Edge/State of Control

Who should Attend

• Regulatory affairs
• Senior management
• Purchasing
• Quality assurance
• Engineering
• Production
• All personnel involved in a U.S. FDA-regulated environment, especially those involved in the establishment, monitoring, and review / audits of outsourced parts and services used in regulated medical products