Course offering number:0907-702
Course ID:
2267
GO BACK TO BROWSE ONLINE TRAINING COURSES PAGE
FDA Quarterly Briefing–July 2009
In Conjunction with Wiley-Blackwell
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:
• Crackdown on IRBs
– True independence
– Oversight
– Follow through on long term studies
Module 2:
• The China Syndrome: Melamine and quality control
– Update on FDA concerns about China API and products
– New FDA on-site inspection plans
– API-user responsibilities
Module 3:
• Medical Devices: new review of all pre-1976 devices
– FDA "grandfather" initiative
– Devices approved before 1976 review standards
– Interpretation of "predicate devices"
Question and Answer Session