[IEEE-bhpjobs] FW: FDA Loses Pivotal Utah Medical Court Case: What Happened & Why: Teleconference December 13

[Esther L]

This teleconference is pricey, but the Utah Medical court decision has 
been covered in the press. It's an interesting case to read about. The 
judge's decision centered on QSR and the definition of validation.

The full decision of the U.S. District Court for the District of Utah, 
Central Division, in United States of America vs. Utah Medical Products, 
Inc. is available at http://www.mckennalong.com/news-pressrelease-1482.html
information is also at:
http://news.corporate.findlaw.com/prnewswire/20051024/24oct20051829.html
http://www.fda.gov/bbs/topics/news/2004/NEW01102.html
http://www.medcompare.com/news.asp?newsid=103834


-----Original Message-----
*From:* FOI Teleconferences [mailto:foionline at foiservices.com]
*Sent:* Wednesday, November 16, 2005 3:53 PM
*To:* Lisa Olson
*Subject:* FDA Loses Pivotal Utah Medical Court Case: What Happened &
Why: Teleconference December 13



<http://www.foiservices.com/tc>

** **

*FDA Loses Pivotal **Utah Medical Court** Case: What Happened & Why**
**Tuesday, December 13, 2005** - 1:00 p.m. to 2:30 p.m. EST (GMT -5)*

FDA has taken legal action to shut down your company and destroy your
entire inventory after giving premarket clearance for your products.
What do you do?  Find out how Utah Medical Products, Inc. dealt with
this potentially business destroying situation and ultimately prevailed
over FDA in court.  Join Joshua Sharlin, a former FDA reviewer and
regulatory affairs expert, as he interviews Daniel Jarcho, lead lawyer
for the Utah Medical legal team, to understand Utah Medical’s defense
strategy – and why the judge ruled against FDA.  This teleconference
will help provide the information and insight needed by drug, device,
and biologic manufacturers in understanding this challenge to the FDA.

**What You’ll Learn:**

     * Why the judge disagreed with how FDA enforced regulations
       regarding process validation, complaint handling and software
       validation
     * What the judge said about FDA’s reliance on evolving industry
       standards
     * How to handle FDA regulations that the judge described as having
       “the virtue of generality and the vice of imprecision”
     * The years of actions Utah Medical took to work with FDA and how
       they finally decided to go to court
     * What types of expert witnesses were used and why
     * Insight into when and how to challenge FDA actions
     * Plus much, much more…

**What You’ll Get:**

     * A history of actions and interactions between Utah Medical and FDA
     * Understanding of why FDA became overly aggressive
     * How Utah Medical tried and failed to resolve the dispute without
       litigation
     * Understanding of the broader regulatory implications of the
       judge’s ruling against FDA
     * Time for questions and answers

**Your Presenters:**

Joshua Sharlin, Ph.D., president of Sharlin Consulting, is a former FDA
reviewer who has trained tens of thousands of people from hundreds of
FDA-regulated companies on how to improve their regulatory processes.



Daniel G. Jarcho, a graduate of Harvard Law School, is a partner in
McKenna Long & Aldridge LLP in Washington, D.C. where he is head of the
firm’s Federal Regulatory Litigation practice group. He was lead counsel
for Utah Medical and has litigated numerous other cases that also have
raised challenges to federal agency policies, rules and regulations.



**Who should participate?  **

Anyone responsible for, or affected by, FDA regulations:

     * Management
     * Legal staff
     * Regulatory affairs personnel
     * Safety specialists
     * Quality assurance/quality control personnel
     * Software developers and their management
     * Auditors and inspectors

*How it works: *
Each toll-free (even if international) dial in is $399; put the
conference on your speakerphone and have as many attendees as you like
for this price. FOI Services will provide a handout a few days before
the conference. The materials may be duplicated for anyone attending.

Go to www.foiservices.com/tc <http://www.foiservices.com/tc> for details
on all teleconferences from FOI Services and to register online. You may
also call 1-800-654-1147 (outside US and Canada +1-301-975-9400) to
register by phone.

Do not reply to this email as it was sent from an unattended mailbox. To
reply or to contact us please send your email to:
infofoi at foiservices.com <mailto:infofoi at foiservices.com>, or mail us at:
FOI Services, Inc. 704 Quince Orchard Road, Suite 275, Gaithersburg, MD
20878.

	



If you prefer not to receive promotional email from FOI Services in the
future please click here
<mailto:de-list-me at foiservices.com?subject=de-list%20%200308488>
<mailto:de-list-me at foiservices.com?subject=de-list%200305368>
<mailto:remove at foiservices.com?subject=Remove%200406028>to send us an
email and **be sure "de-list 0308488"** appears in the subject line.

	






-- 
-- Esther L., esther_L (at) ieee.org, Speaking only for myself.
If your email to me bounces, check the _L and the H in esther.
-------------- next part --------------
An embedded and charset-unspecified text was scrubbed...
Name: file:///C|/DOCUME%7E1/ESTHER/LOCALS%7E1/TEMP/nsmail.txt
Url: http://rtpnet.org/pipermail/ieee-bhpjobs/attachments/20051118/8c607981/nsmail.txt
-------------- next part --------------
No virus found in this outgoing message.
Checked by AVG Free Edition.
Version: 7.1.362 / Virus Database: 267.13.4/175 - Release Date: 11/18/2005