Why and How to Monitor A Clinical Lab

Rumors and Stories: I've been hearing stories about FDA inspectors who were concerned about the clinical or technical laboratory data for trials. They pulled out a copy of Part 58—Good Clinical Practices (for non-clinical laboratories) and started to apply the regulations point-by-point.

Inspectors are trained to follow the data. They look for the first recording of a number and follow it through all the way to reporting. If they question that first number, the whole study is in jeopardy.

Here's the business issue:
Your company is doing a clinical trial on your new device. Without careful monitoring of the lab tests FDA might query your efficacy claims; they may doubt the validation results from the mass spec data although the lab you used is fully certified.

The e Conference:
Our expert speaker, Olive Wolfe, will present a scenario to show how lab data is critical to the device’s efficacy claims. She will show why it's essential to visit the lab to review day to day operations. She will provide a check list to be used to evaluate the lab’s performance and operation onsite, and she will also show how this applies to new tests, instruments and reagents.

The playbill (you will receive):
Each audience member will receive:
1. CAP check lists for Lab inspections
2. CLIA Regulations
3. PowerPoint slides.
4. An expert speaker.
5. Chance to listen to other's QnA.
6. CEUs and certification of attendance.

The presenter:
Olive Joy Wolfe, MS, is the president of Clinical Consultants, Inc., which specializes in clinical studies, 510(k)s, PMAs, and Quality Assurance. Previously Ms. Wolfe was Senior Director of Clinical Research at Health Learning Systems in New Jersey, and before this worked as a Clinical Research Scientist for several years.  She can be reached at clincon1@optonline.net.

Audience suitability:
[x] Clinical research professionals
[x] Monitors
[x] People who work in clinical device trials
[x] Marketing professionals
[x] Statistical professionals
[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.