In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, ...
Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections. Since 2020, FDA has delayed many routine inspections due ...
Managers of FDA-regulated firms must be proactive in how they manage their company's compliance with good manufacturing practices regulations. In September 2004, the US Food and Drug Administration ...
As a background summary, CGMP represents the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMP guidelines provide for systems that give ...
The Food and Drug Administration (FDA) is a Health and Human Services (HHS) agency that regulates clinical investigations of products under its jurisdiction including drugs, biological products, and ...
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