In the highly regulated world of the pharmaceutical and medical device industries, a buzzword that h...
In January 2025, the FDA released a draft guidance titled Obesity and Overweight: Developing Drugs a...
The role of ISO 9001 in quality management is to provide a standardized framework for Quality Manage...
Medical device audits are vital for ensuring compliance, maintaining quality, and safeguarding patie...
The COVID-19 pandemic exposed significant vulnerabilities in global supply chains, challenging long-...
The medical device industry operates under a complex web of regulations, with 21 CFR Part 820, commo...
Creating a quality culture within the workplace is foundational to quality compliance. The keystones...
The introduction of artificial intelligence (AI) in the quality and regulatory functions is not a ne...