[IEEE-bhpjobs] May 25 3pm: Validation as an Engineering Activity talk, NC Biotech Ctr

[Esther L.]

I have put the registration form PDF at
http://www.rtpnet.org/ieee/bhpjhc/Validation%20Engineering%20FLYER-Registration%20Form%20r3.pdf
3pm - 5pm, Wednesday, May 25
fee: $25 for ISPE members and NC Biotech mailing list members, $35 for 
others.


Validation as an Engineering Activity: Ruling by North Carolina Board of 
Examiners for Engineers and Land Surveyors
Presented by:
Dave Tuttle, Board Counsel
North Carolina Board of Examiners for Engineers and Land Surveyors
Date: Wednesday May 25, 2005
Time: 3:00 to 5:00 PM
Location: North Carolina Biotechnology Center, or via Web-Conference
In the ISPE CASA Spring 2005 newsletter, an article on this subject was
published titled Validation as an
Engineering Activity. Excerpts follow:
A recent ruling by the North Carolina Board of Examiners may affect the
way validation companies do business, and may
impact pharmaceutical and biotech companies that manufacture products in
North Carolina.
In 2004, the North Carolina Board of Examiners received complaints that
several firms performing validation services were
practicing, or offering to practice, engineering in North Carolina.
After conducting an investigation of the complaints, and
after receiving testimony and evidence from several of the firms
charged, the Board of Examiners concluded that portions of
the validation process are considered to be engineering activities and
thus must be done under the charge of a licensed
Professional Engineer and a licensed engineering firm. As a result, the
Board issued letters to four validation companies,
stating they were “in violation of G.S. 89C and G.S. 55B by offering to
practice or practicing engineering in North Carolina
without being licensed by the Board.”
… Kentucky, Alabama, West Virginia, Georgia, and Virginia have all
confirmed that at least some aspect of validation
constitutes the practice of engineering.
Dave Tuttle, Board Counsel for the North Carolina Board of Examiners for
Engineers and Land Surveyors, has
agreed to make a presentation to explain the actions of the board and to
field questions on this issue.
  In order to
reach all of our membership with this
important information, ISPE CASA is offering two ways to attend this
important event:
1. Attend in person at the North Carolina Biotechnology Center in RTP, NC.
2. Attend by web-conference using your internet ready desktop PC and
telephone.
REGISTRATION DEADLINE IS THURSDAY MAY 19!
NC BIOTECH MAILING LIST QUALIFIES FOR MEMBER RATE!
SEE ATTACHED REGISTRATION FORM AND DIRECTIONS
&
Validation as an Engineering Activity
North Carolina Biotech Center or Web-Conference
May 25, 2005 - 3:00 to 5:00 PM

Questions??? Call Tom Stevens, 919-669-4851, or John Davis,
919-861-8112, or email:
tom.stevens at perfval.com or john_davis at serentec.com.
Please post on your bulletin board and make multiple copies if needed!
Registration DEADLINE is Thursday, May 19.

-- 
--  Esther L.,  esther-L at alumni.virginia.edu
Speaking only for myself