I Received An FDA Form 483 – What Next?
The Whats, Whys, Dos, and Do-Nots Following an FDA Audit Today, we’re taking a look at the role an FDA Form 483…
Auditing the Instruction: Answering FAQ’s From Students
The world of Quality Management can be dizzying. You’ve slogged through brochures, waited through webinars, and sat on…
Big Changes Ahead: 2025-2026 Quality Assurance Overhaul-Is Your Business Ready?
Big Changes Ahead: 2025-2026 Quality Assurance Overhaul–Is Your Business Ready? Quality standards are getting a major…
The FDA QMSR Final Rule: Get Ready for a Quality Management System Revolution (and Why You Need to Act Now)
On January 31st, 2024, the FDA released its final Quality Management System Regulation (FDA QMSR) rule, marking a…