Drug Regulatory Compliance/Drug Approval and Preapproval Inspection
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Who Should Attend
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Description
This continually updated course covers current FDA regulatory compliance with respect to marketing human drugs and biologics, including the FD&C Act, case law, and the FDA?s authority to promulgate and enforce regulations. Among the topics to be discussed will be: FDA?s regulatory policies, how they develop and where they are documented; the regulatory process, including regulatory and pre-approval inspections, recalls, warning letters, injunctions, seizures and criminal prosecutions; cGMP; compliance programs, how they develop and are administered; compliance policy guides; the Regulatory Procedures Manual and the Inspection Operations Manual. Laboratory and process validation, NDAs, ANDAs, and other pre-approval documents, stability, the Establishment Inspection, the FD-483 and interactions with FDA?s inspectors (investigators) will also be discussed. The course will have applications to drugs and biotechnology-derived products.