Preparing for an Audit
Preparation is essential for any audit or investigation, especially because of the escalating complexity and overlap of global quality regulations. Life Science companies that serve multiple national markets or rely on dispersed supply chains will commonly face compliance challenges from regulatory agencies including the US Food and Drug Administration and the European Commission, and international organizations such as the International Committee on Harmonisation and the International Standards Organisation and national governments. While all facilities within a regulated company should be audit-ready at any time, there are certain triggers that might warrant additional levels of preparedness.
Contact UL EduNeering's Advisory Services team at 609.627.5300 or email EduNeeringInquiry@UL.com to learn how we can help you prepare for your next FDA Audit.
The FDA's Cooperative Research and Development Agreement (CRADA) with UL EduNeering has created a collaborative partnership between the two organizations, resulting in courses developed with, and used by FDA inspectors and industry professionals worldwide.
UL serves as AdvaMed's exclusive online compliance partner, providing its members with educational resources to maintain regulatory compliance and professional knowledge. Those programs accommodate the needs of both emerging companies and well-established device firms.