FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
21
11, 2024
30
10, 2024
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]
13
06, 2024
Customer Quality Management: How the QMS Can Help
Customer complaints are a fact of life in any industry. Even though manufacture [...]
29
05, 2024
The Power of Change Management Tools
Look through even a few FDA warning letters, and you’re likely to find violation [...]
22
02, 2024
Why Change Control is Important: Tips for Manufacturers
Change is a constant in manufacturing, and is both necessary for innovation and [...]
21
06, 2022
5 Ways an EQMS Resolves Change Management and Change Control Pains
In the life science industry, adjustments are a necessary element throughout the [...]
