MessageFrom: Henig, Anne M
Sent: Friday, July 09, 2004 10:29 AM
To: Butler, Jennie C
Cc: Dockets, FDA; Henrikson, Erik N
Subject: FW: Updated Public Meeting Presentations

Jennie,
  
Can you make sure these comments are put into the Docket, number 2004N-0133?  As always, we appreciate all your hard work.  Many thanks!  

Anne M. Henig 
FDA/Center for Drug Evaluation and Research 
Executive Operations Staff 
301-443-5576 
heniga@cder.fda.gov 


-----Original Message-----
From: Siôn Wyn [mailto:sion.wyn@conform-it.com] 
Sent: Friday, July 09, 2004 5:21 AM
To: Famulare, Joseph; Henrikson, Erik N; Smith, George
Cc: Conformity
Subject: Updated Public Meeting Presentations


Friends

You should have received the official ISPE/GAMP Part 11 comments to the docket. As well as the main comment letter in Word, there were two attachments (the presentations intended to be given at the Public Meeting). Following the cancellation of the meeting one of the the authors included further information in the Powerpoint Notes View to cover the verbal part of his intended presentation. I'm not sure if ISPE actually sent through the UPDATED  and most recent version of the presentations with these Notes View additions in one of them. Just in case, here are the latest versions.

All the most important GAMP comments and Part 11 suggestions are included in the official letter from ISPE, but I thought you should have these most recent versions of the presentations as well.

Regards
Sion


Sion Wyn
Director
Conformity
PO Box 7 Llanrwst
LL26 0ZF, UK
T. +44 (0) 1492 642622
sion.wyn@conform-it.com