FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
How an EQMS can Reduce CAPA and Complaint Observation Trends
As we move through 2022, we look forward to new opportunities, new challenges, [...]
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
This article is part two of a two-part series focused on GMP quality audit manag [...]
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]
