FDA Quarterly Briefing–January 2009 Training Course :

<strong>Course Schedule - January 13, 2009 at 11:00 a.m. - 12:30 p.m. (EST) </strong><br/><br/>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:<br><br> <b><u>Module 1:</u><br>   • Design Space: </b>a new FDA concept that permits deviations <br>     in design of medical devices and production processes <br>     without regulatory involvement or re-approval<br><br> <b><u>Module 2:</u><br>   • Off Label Drugs:</b> FDA crackdown on this process of large <br>     scale use of a drug for treatment of a disease never <br>     reviewed or approved<br><br> <b><u>Module 3:</u><br>   • Process Validation: </b>Risk Based (Q8, Q9, Q10) and <br>     Quality by Design new approaches<br><br> <b>Question and Answer Session</b>