Quality Coe
Complete Guide to FDA Inspection Readiness
Learn how to prepare for an upcoming FDA inspection, what to expect during the inspection, and steps to take following inspection close.
Critical Steps for Writing an Impactful Clinical Audit Report
In this blog, we share tips and best practices for writing an impactful clinical audit report.
Navigating the FDA Emergency Use Filing Process
Partnering with Advarra, one nonprofit successfully obtained an Emergency Use Authorization from the FDA within five weeks.
For FDA Inspection Readiness, Accountability is Key
An Advarra expert provides insight in this Q&A session on the FDA inspection readiness process, including how to improve current workflows.
Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the webinar- FDA Updates: BIMO – What Sponsors Need to Know.
Steps to Implementing a Quality Management System
Read our blog to learn more about quality, its role in clinical research, and how to implement a management plan.
ReadyQMS Info Sheet
Advarra ReadyQMS, a quality management system for biopharmaceutical companies, reduces risk and ensures regulatory compliance.
Steps to Implementing a Quality Management System
This white paper outlines the full implementation process of a quality management system and how to avoid conflict by focusing on quality.