Who Should Attend
Because of its comprehensive content, this course should prove most valuable to:
• Regulatory Affairs Professionals
• Scientists/Laboratory Staff
• 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.
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.