Critical Steps for Writing an Impactful Clinical Audit Report
The amount of detail required in an audit may vary – ranging from an executive, high-level summary with detailed observations,
quality coe
Navigating the FDA Emergency Use Filing Process
In an effort to create safe, effective, and affordable ventilators to help combat the foreseeable shortages due to COVID-19, one
For FDA Inspection Readiness, Accountability is Key
Dawn Wydner, former Food and Drug Administration (FDA) Consumer Safety Officer, LCDR, and current Managing Expert for Advarra’s Quality Center
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the first in the webinar series – FDA Updates: BIMO
Implementing a Quality Management System
Many research and development (R&D) organizations across the industry have limited access to a quality department in the early stages of