Human Factors in CAPA Part I: How to Improve Employee Engagement
At its core, corrective and preventive action (CAPA) is about systematically ev [...]
7
05, 2025
17
04, 2025
Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing
Every day, quality leaders face a variety of production and process issues. Whi [...]
5
12, 2024
AI in Medical Device Manufacturing: How It’s Transforming an Industry
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]
21
11, 2024
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]
14
11, 2024
Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufac [...]
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 [...]
24
10, 2024
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with lev [...]
9
10, 2024
The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software
In the highly regulated world of life sciences, data integrity is not optional [...]
29
08, 2024
Ways to Influence Stakeholder Buy-In During the CAPA Process
How can a quality manager secure stakeholder engagement and hold individuals ac [...]
22
08, 2024
CAPA is a Process, Not a Project: 3 Key Strategies for Success
The challenge of the quality manager is to convince stakeholders of their respo [...]
