From: JEnglish@technip.com Sent: Friday, June 04, 2004 4:01 PM To: HENIGA@cder.fda.gov Cc: fdadockets@oc.fda.gov; SaOstrove@technip.com Subject: Re: Part 11 meeting - Docket number 2004N-0133 - initial transmittal Anne: Please find attached the text of my presentation. I am sending it now as a precaution against some difficulty with the powerpoint. 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) Please advise if there are any problems opening it, or with the choice of format. As a precaution, since I will be away form 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