Course offering number:0901-704
Course ID:
2232
FDA Quarterly Briefing–January 2009
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is designed for professionals in the pharmaceutical, device and biologics industries. It will be especially beneficial to:-
Regulatory/QA Managers
- Directors and VPs
- Planning Executives anticipating FDA changes
Description
This quarter's briefing is a careful distillation identifying the three most important new initiatives, regulatory changes and innovations from the
FDA, and places them in context for the pharmaceutical, biological and device professional. This 90-minute accredited online training is divided
into three sections, each section devoted to a new FDA regulation or initiative. The topics are:
Module 1:
• Design Space: a new FDA concept that permits deviations
in design of medical devices and production processes
without regulatory involvement or re-approval
Module 2:
• Off Label Drugs: FDA crackdown on this process of large
scale use of a drug for treatment of a disease never
reviewed or approved
Module 3:
• Process Validation: Risk Based (Q8, Q9, Q10) and
Quality by Design new approaches
Question and Answer Session