FDA Drug Development and Compliance
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This course is available as a client site course. Please click here for more information.
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
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 also benefit from this course. The program also
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
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 biotechnologyderived
products.