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
