A Softer, Gentler FDA Inspectorate?
By Shawn M. Schmitt Let’s be blunt: Device makers aren’t particularly happy when the U.S. Food…
The Auditor
An Exemplar Global Publication
- SQF Edition 10: What’s Inside
- Exemplar Global’s Online Expo Launching Soon
- Psychological Safety and Why Auditors Need It
- Building a Quality Culture: The Role of Leadership
- Process Validation in Medical Device Manufacturing: Building Confidence in Compliance and Quality
- Why Growing Factories Need Integrated Management Systems
- The Critical Importance of Risk Management: Lessons from Real-World Failures
- Picking the Right Audit Sample: A Practical Guide for New Auditors
- CAPA vs. Nonconformance in ISO 13485: Teammates, Not Twins
- Business Acumen for the Quality Professional: Part One