Introduction to the FDA and FDC Act

Here's the business issue:
To be successful with the FDA you need an understanding of FDA's organizational structure, the framework and content of the Food, Drug, and Cosmetic Act, and its related regulations. In the absence of such knowledge, you cannot work effectively with FDA reviewers and field investigators or advance as a professional in these fields. 

The e Conference:
This lively and informative course is designed to introduce you to the basics of FDA regulation from the fundamentals to Agency organization and priorities, premarket submissions, and enforcement.  It will provide a foundation for quality, professional interactions with FDA.

This first course in a 4-part series consisting of:
An Introduction to FDA....
Regulatory Strategies
The Successful IDE
The Successful 510k

The playbill (you will receive):
1. PowerPoint slides.
2. An expert speaker.
3. Chance to listen to other's QnA.
4. CEUs and certification of attendance.

The presenter:
I've invited Janice Hogan is a partner in the offices of Hogan and Hartson LLP and a member of the firm’s Food, Drug, Devices, and Agriculture Group. Her practice focuses on the representation of medical device [and other] manufacturers before FDA. She is a biomedical engineer and specializes in regulatory counseling related to high technology medical products. You can reach Ms. Hogan at http://www.hhlaw.com/jmhogan/

Audience suitability:
[x] Regulatory professionals.
[x] Clinical research professionals.
[x] People who work in clinical device trials.
[x] Marketing professionals.
[x] Monitors.
[x] Statistical professionals.
[x] Managers who sign off on clinical trials.
[x] Executives who are planning their companies futures.

The purchase is $422 for OnDemand access and $472 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.