Description
<strong>Course Schedule - March 23-25, 2009</strong><br/><br/>This <b>continually updated</b> course covers current FDA drug
development issues and 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.
