[IEEE-bhpjobs] 21 CFR Part 11 group meeting June 15 - Japan MHLW guideline on Electronic Records and Electronic Signatures

[esther L]

---------- Forwarded message ----------
From: Jeff Eckberg <jeckberg at pharmalinkfhi.com>
Date: Jun 6, 2006 8:57 AM
Subject: PEERS Meeting - June 15, 2006

Hi PEERS,

Just a friendly reminder that the June PEERS meeting will be held on 
Thursday, June 15th at the Quintiles Bradford Building, Room 6344. 
Note:  This is not our usual location.  Directions are provided below.

Lisa has rounded-up what sounds like some great guest 
speakers...visitors from Japan.

The agenda is as follows...

1. Agree on agenda
2. Introduction of new members
3. Reminder of PEERS confidentiality statement.
4. Review of recent 483s and warning letters pertaining to 21 CFR Part 11.
5. Review of past training courses and conferences attended - other news.
6. Announcements of any upcoming training, conferences, etc.
7. Presentation by Masamitsu Watanabe, Managing Director and Kenichi 
Nakano, Compliance Consultant.  Both are with Knowledgeware Division, 
Yamatake Corporation.

         Their presentation will cover the following:

         The Japanese Ministry of Health, Labour and Welfare issued a 
guideline
         on Electronic Records and Electronic Signatures on April 1st, 
2005.  The
         presenters will cover its requirements and compare them with 
Part 11.
         They will also cover Japanese pharmaceutical companies' 
reaction to /
         application of the guideline.

8.  Web Site Update (Hal Bredbenner and Jim Box)
9.  "Election" of 3rd Quarter Chairperson and Recorder
10. Upcoming meeting programs/ speakers

11.  Any Other Business

Anyone who would like to add to the agenda, or needs the call-in number, 
please contact me.


_____________________

Jeff Eckberg, RAC
PEERS Chairman
Director, Quality
PharmaLinkFHI
4309 Emperor Boulevard
Suite 400
Durham, North Carolina, 27703
(919) 484-1921 ext. 213
<jeckberg at pharmalinkfhi.com>
www.pharmalinkfhi.com

Directions:
Quintiles Bradford Building, just east of RTP
Take I-40 to Miami Boulevard Exit (#281).
Turn left onto South Miami Boulevard (note: this is the same as 
54/Chapel Hill Rd., if coming from the east).
Proceed straight for about 3/4 mile (pass Wendy's, McDonalds).
Bradford Building is on the left (on the corner by the light to Emperor 
Drive (Imperial Center)).
Low gray building.
Sign in at security desk.




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


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