Aiming for CLIA Waiver

Here's the business issue:
Your company makes an in-vitro diagnostic product. How can you, as a regulatory professional, get the a CLIA waived status from FDA, so that marketing can offer the product to the maximum number of laboratory customers?

The e Conference:
Last January FDA issued a guidance document on "CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices." In this e Conference, IVD expert Dr. Gail Radcliffe will interpret the guidance based on her vast experience in the field, and will supplement her interpretation with feedback from FDA. She will attempt to predict your questions in white paper fashion; providing guidance of her own on how to maximize your chances of success. The presentation will be supplemented case studies to help clarify the issues.

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

The presenter:
Gail E Radcliffe, PhD assists IVD device, medical device, and biotech companies with technical, marketing, regulatory, and business development issues. She brings a unique viewpoint to the overall process of product development. Dr. Radcliffe helps emerging companies assess platform technologies to meet customer needs, conducts technical due diligence, and provides regulatory strategy assistance. She holds several patents and has worked with clients to obtain funding through angel investments, venture capital and Small Business Innovation Research (SBIR) grants. You can reach her at gradcliffe@charter.net. 

Audience suitability:
[x] Regulatory professionals who make submissions for IVD devices
[x] Clinical research professionals who's IVD trial data will be used in submissions
[x] Statistical professionals who's IVD data analyses will be used in submissions
[x] Managers who sign off on clinical trials
[x] Executives who are planning their companies futures

The purchase is $420 for OnDemand access and $470 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.