
FDA Inspection and Enforcement Course Guide
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A proactive 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.
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.
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.
FDA Inspection and Enforcement Course Guide