Course offering number:0903-407
Course ID:
587
U.S. FDA Drug Development and Compliance
March 23-25, 2009
New Brunswick, NJ
Who Should Attend
Because of its comprehensive content, this course should
prove most valuable to:
• Regulatory Affairs Professionals
• QA/QC
• Scientists/Laboratory Staff
• Supervisors
• Engineers
• Management
• Manufacturing Personnel
• Legal Staff
Those who are new to the industry or to their current position
and do not have an in-depth knowledge of the FDA and its
workings will benefit from this course. The program provides
an opportunity for more experienced personnel, including
middle and upper management, to update and broaden their
knowledge.
Description
This continually updated 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.