FDA Audit & Inspection Readiness

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.

  • FDA Inspection Readiness Workshop

    UL instructors will train your staff on how to prepare your organization for an FDA audit, understand the FDA inspection process, with emphasis on how to interface with FDA investigators, and recommended audit Dos & Don'ts.

  • Mock Audit

    UL conducts FDA mock audit inspections to simulate routine and pre-approval FDA audits. The UL mock audit team helps prepare your staff to handle an FDA audit and it will provide a full gap analysis for QSR, cGMP, Part 11, ICH and other regulatory standards.

  • Audit Remediation Services

    Whether your organization has audit findings/observations from official regulated body audits, internal audits or UL mock audits, UL remediation services can partner with you to provide consultation and support to create and implement remediation plans for all findings.

  • Supplier Audit Program

    UL EduNeering's experienced and highly qualified auditors provide your company the assurance that your suppliers are complying with your standards, reducing the risk to your organization through a robust outsourced supplier audit capability ranging from a single 1-2 day supplier audit to annual contracts for managing your complete supplier auditing program.