The Paradigm Shift in AI: From “Using” to “Delegating”
Why Double Standards Are Dangerous: The Critical Importance of Unified SOPs in Regulated Industries
Team Roles and Responsibilities in Inspection Response
AI as Co-Pilot, Humans as Captain: A New Era of Collaborative Partnership
Why Software Risk Management Does Not Quantify Probability of Occurrence
The Seven Stages of CAPA: A Comprehensive Guide for Quality Management
Understanding Labeling Definitions in the United States: Navigating FDC Act, QSR, and QMSR Requirements
FDA Office of Inspections and Investigations: Organization and Inspection Operations