ComplianceWire® Guide to U.S. FDA Inspections and Enforcement

Introduction to UL Solutions ComplianceWire^® approach to U.S. Food and Drug Administration’s (FDA) inspections 

Concerns in life sciences industry are growing regarding the safety of medical products used by the American public. The United States Congress has solicited testimony about the U.S. Food and Drug Administration’s (FDA) inspection and enforcement actions, spurring the demand for greater vigilance by the FDA in both the breadth and frequency of inspections. At the center of these intersecting issues is a life sciences industry attempting to understand – and adhere to – the FDA’s requirements. 

FDA Inspections and Enforcement Course Listing Highlights 

• Curriculum of over 50 courses 
• Content co-developed and/or reviewed by the FDA and used to train FDA investigators 
• Available via ComplianceWire^®, 21 CFR Part 11 and EU Annex11 Validation and Compliance Learning Management System (LMS) 
• Tools to help drive employee comprehension of critical operating procedures, regulatory requirements and performance expectations 

Our relationship with the FDA: the Cooperative Research and Development Agreement (CRADA) 

In 1999, UL Solutions and the FDA established the Cooperative Research and Development Agreement (CRADA). This agreement enables the FDA to standardize training courses and deliver them online to thousands of regulators and investigators. Plus, FDA-regulated companies can now access online content provided, reviewed and used by the FDA. 

Summary 

UL Solutions ComplianceWire^® quality, compliance and learning help companies develop and implement compliance programs that translate into practical benefits such as cost savings and the protection of a company’s reputation and credibility with its regulators, stakeholders, and medical community and the public.