From: JEnglish@technip.com Sent: Friday, June 04, 2004 4:55 PM To: HENIGA@cder.fda.gov Cc: fdadockets@oc.fda.gov; SaOstrove@technip.com Subject: Re: Part 11 meeting - Docket number 2004N-0133 - Replacement and Final transmittal Anne: Please find attached the text of my presentation and the powerpoint slides. Please note this pdf has been changed and replaces the first transmittal This is the requested presentation as per you e-mail and confirmation letter dated 25 MAY 2004. (See attached file: JEnglish_FDAPart11_Docket2004N-1033.pdf)(See attached file: JEnglish_FDAPart11_Docket 2004N-0133.ppt) Please advise if there are any problems opening it, or with the choice of format. As a precaution, since I will be away from e-mail until Monday evening, you should cc: Dr Steve Ostrove with any issues. (He is included on this email as well. His internet address is SAOstrove@technip.com) Best regards, John English, Principal Validation Consultant TECHNIP BioPharm Inc. 106 Allen Road, Suite 300 - Rm 3261 Liberty Corner, NJ 07938 - USA Tel: +1.908.604.7552 Fax: +1.908.604.7501 Cell:+1.973.727.5679 E-mail: jenglish@technip.com Technip BioPharm (In Progress): http://www.technipbiopharm.com Technip Life Sciences Page: http://www.technip.com/english/experience/life.htm