4 min read
Scope of Statistical Applications in Risk-Based Quality Management (RBQM)
Risk-based quality management (RBQM) represents a core area of clinical development that systematically focuses on both safety and data quality risks...
Quality
6 min read
Building Blocks of Quality: The Role of Design Control in Medical Device Development
Design Control is a critical quality management system process that allows for a concept be developed and evolve into a reliable and safe product...
3 min read
Risk Management in Pharmacovigilance
It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits...
2 min read
Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule
On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...