Part 11 meetingFrom: Sanjeev Kumar [SKumar2@Apotex.com] Sent: Friday, June 04, 2004 3:58 PM To: Henig, Anne M; fdadockets@oc.fda.gov Subject: RE: Part 11 meeting -- docket number 2004N-0133 Dear Anne M. Henig, This is in response the message below; Let me take this opportunity to thank you and your agency for involving us in 21CFR Part11 development process. I am appending a powerpoint presentation of 11 slides keeping in view 10 minutes window that has been provided to me. Please let me know if have any clarifications or you are not able to open this file. Thanks and hope to see you in the meeting on 11th. Sanjeev Kumar Manager, Computer System Validation - Compliance Apotex Inc., Etobicoke 416-675-8421 skumar2@apotex.com -----Original Message----- From: Henig, Anne M [mailto:HENIGA@cder.fda.gov] Sent: Monday, May 24, 2004 4:37 PM To: Sanjeev Kumar Subject: Part 11 meeting Sanjeev, Thank you for registering to speak at the Food and Drug Administration (FDA's) public meeting to discuss various topics concerning our regulations on electronic records and electronic signatures in Part 11 (21 CFR Part 11). The goal of this meeting is for FDA to consider public input as we evaluate potential changes to Part 11. Your expertise and input would be most beneficial to the FDA and we are delighted to have you participate. Due to the number of registrants, all presentations are strictly limited to 10 minutes each. Please introduce yourself and your affiliation. You are scheduled to speak at 11:50 a.m. Attached for your information is the DRAFT agenda. You will be seated in the order of presentation as indicated on the agenda. If you plan to present slides as part of your presentation, please use Microsoft PowerPoint. Please submit your presentation electronically, including the docket number 2004N-0133 in the subject line of your email message, to both Anne Henig at heniga@cder.fda.gov and to FDA Dockets at fdadockets@oc.fda.gov by close of business on June 4, 2004. In addition, please bring a copy of your presentation on a floppy disk the day of the meeting. The public meeting will be held on June 11, 2004 from 8:00 a.m. to 4:30 p.m. at the National Transportation Safety Board (NTSB) Boardroom and Conference Center, located at 429 L'Enfant Plaza, SW, in Washington, DC. We recommend that you arrive to NTSB no later than 7:45 a.m. Directions to the NTSB Boardroom and Conference Center are as follows: The street entrance is located on Lower 10th Street just below the L'Enfant Plaza Promenade running between D Street and Frontage Road, SW (next to the public garage entrance). The NTSB Boardroom and Conference Center can also be reached by Metro, using the L'Enfant Plaza station on the green, yellow, blue or orange lines. From the L'Enfant Plaza Metro, take the 9th and D Street exit, walk through the shopping plaza towards CVS and take the escalator down to the lower level. The NTSB Boardroom and Conference Center will be to the left. Directions from the local airports will be provided upon request. Please feel free to contact me on 301-443-5576 if you have any questions or concerns. I will look forward to seeing you on June 11th! <> Anne M. Henig FDA/Center for Drug Evaluation and Research Executive Operations Staff 301-443-5576 heniga@cder.fda.gov