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DATE 2005-11-01

HANGOUT

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MESSAGE
DATE 2005-11-15
FROM Ruben Safir
SUBJECT Subject: [NYLXS - HANGOUT] [Fwd: Press Release: Second Annual FDA Information Management
From owner-hangout-at-mrbrklyn.com Tue Nov 15 16:31:29 2005
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Subject: [NYLXS - HANGOUT] [Fwd: Press Release: Second Annual FDA Information Management
Summit Nov. 30 - Dec. 3, 2005]
From: Ruben Safir
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-----Forwarded Message-----
> From: Pharma Update News Service
> To: ruben-at-mrbrklyn.com
> Subject: Press Release: Second Annual FDA Information Management
> Summit Nov. 30 - Dec. 3, 2005
> Date: Tue, 15 Nov 2005 16:18:31 -0500
>
>
>
>
>
>
> PRESS RELEASE: FDAnews Presents the 2nd Annual FDA Information
> Management Summit: Delivering the Right Data, the Right Way on Nov. 30
> - Dec. 2, 2005
>
> PRESS RELEASE
> Phone: (888) 838-5578, (703)-538-7600
> Fax: (703) 538-7676
> Website: www.fdanews.com/infosummit
>
> WASHINGTON DC, USA -- PHARMA UPDATE NEWS SERVICE(TM) -- NOVEMBER 15,
> 2005: Evolving requirements and the FDA's new risk-based view of
> information management can transform your computer systems,
> applications and even email into warning letters, negative publicity
> and crippling delays.
>
> Before you buy software, assess risk or validate systems, you must
> know:
> * What the FDA expects: FDA insiders explain the agency's
> expectations for information management during 2006 - and the
> new approach and priorities for enforcement.
> * What industry advises: Compliance experts and practitioners
> from drug and device companies map out best strategies for
> managing information from R&D and trials to manufacturing and
> marketing.
> * What your colleagues are doing: Network with executives ready
> to share real-world experience on which software works best,
> what information management changes they're making, where
> unexpected problems arise and how they're fixing them.
> BENEFITS OF ATTENDING:
> * Learn how to use risk assessment in Part 11 compliance
> * Gain knowledge on how to prepare for risk-based inspections
> * Latest policies on esubmissions from CDER, CBER and CDRH
> * Best practices for system validation, erecords and esignatures
> * Strategies for safeguarding security, data integrity and
> privacy
> TOPICS:
> * Preconference Workshop: Strategies to Manage Risk in
> Electronic Records and Processes
> * Keynote Address: The FDA's Information Management Goals for
> 2006 and Beyond
> * Update on CBER's eSubmission Policies and Procedures
> * Better Understanding the FDA's Regulatory Expectations
> * Update on CDHR's eSubmission Policies and Procedures
> * Protecting the Security and Integrity of Clinical Trial Data
> * Update on Clinical Data Standards Consortium (CDISC) Standards
> * Data Privacy and HIPAA Concerns
> * Building and Maintaining Data Warehouses for Clinical Data
> * Best Practices for Computer System Validation and eRecords and
> eSignatures Compliance
> * SAFE-BioPharma Standards Update
> * Update on the Latest FDA eLabeling Requirements
> * FDA Enforcement and Computerized Systems Compliance
> * Importance of Initiatives Underway at the FDA to Better
> Facilitate Information Sharing Via
> * Electronic Means
> * Security of eRecords - Can I Still Use My System?
> * Utilizing Risk Assessment in Managing Part 11 Compliance
> * Spreadsheet Validation and Database Compliance Strategies
> EXPERTS FEATURED:
> * James Rinaldi, formerly chief information officer at the FDA,
> currently chief information officer of NASA's Jet Propulsion
> Laboratory, Keynote Speaker
> * Dr. Scott Gottlieb, deputy commissioner for medical and
> scientific affairs, FDA
> * Lisa Olson, principal consultant, SEC Associates (chairwoman)
> * Martin Browning, president, EduQuest
> * Gary Secrest, chief information security officer, Johnson &
> Johnson (chairman of the board SAFE-BioPharma Association)
> * Wayne Kubick, Sr. vice president and chief quality officer,
> Lincoln Technologies (leader of the Submission Data Standards
> team and CDISC technical director)
> * Gordon Richman, vice president of strategic compliance
> consulting and general counsel, EduQuest
> * Ty Mew, president, Ofni Systems
> * David Harrison, principal consultant, ABB Process Systems
> WHO WILL BENEFIT:
>
> This summit is especially designed for those involved with:
> * Regulatory affairs
> * IT management
> * QA/QC
> * Validation
> * Clinical trial data
> * Laboratory information
> * Software development
> * Internal and external communications
> * Corporate legal affairs
> Send Your Compliance Team for Maximum Benefit. Get state-of-the-art
> training for you and your team in just three days. Significant tuition
> discounts are available for teams of three or more people from the
> same company. You must register at the same time and provide a single
> payment to take advantage of the discount. Call +1 (703) 538-7600 for
> details.
>
> ABOUT THE LOCATION:
>
> Hyatt Regency Bethesda Hotel, Bethesda, Maryland (Washington, D.C.).
> Directly on the metrorail red line at Bethesda Metro Center, the Hyatt
> Regency Bethesda Hotel is central to Washington's world of life
> science companies, researchers and regulators. The hotel is minutes
> from FDA headquarters, the campus of NIH, Washington D.C.'s famed
> monuments and museums, Bethesda Naval Medical Center and Montgomery
> County's thriving biotechnology corridor.
>
> BONUS FOR ATTENDEES:
>
> Register at any time and receive a free 3-month subscription to
> FDAnews' PharmaDevice IT Report. This biweekly newsletter, provides
> case studies, expert interviews and practical advice on how to comply
> with 21 CFR Part 11 requirements and other technology initiatives at
> the FDA and in the industry.
>
> TUITION:
>
> 3 cost-effective learning options:
> 1. Complete Conference and Workshop Passport: $1,990 (you save
> $300 - the best value). Tuition includes the preconference
> workshop, all conference sessions, conference and workshop
> written materials, two breakfasts, two luncheons, one
> reception, refreshments and two certificates of attendance
> (workshop and conference).
> 2. Conference Sessions Only: $1,695 includes all conference
> presentations, conference written materials, two breakfasts,
> one luncheon, one reception, refreshments and a conference
> certificate of attendance.
> 3. Preconference Workshop Only: $595 includes the preconference
> workshop, workshop written materials, one luncheon,
> refreshments and a workshop certificate of attendance.
> Payment is required by the date of the conference. We accept American
> Express, Visa and MasterCard. Make checks payable to FDAnews.
>
> REGISTRATION INFORMATION:
>
> Register online at www.fdanews.com/infosummit for the FDAnews 2nd
> Annual Information Management Summit Conference
>
> Or Call: toll free (888) 838-5578 (inside the U.S.) or +1 (703)
> 538-7600.
>
> SATISFACTION GUARANTEED:
>
> You must be 100 percent satisfied with this learning opportunity or
> we'll refund your tuition or extend a credit to a future conference
> sponsored by FDAnews.
>
> SPONSORED BY:
>
> FOR E-MAIL ADDRESS CHANGE, ADD OR DELETE REQUESTS:
>
> For changes or additions, please email your request to:
> listmgr-at-PharmaUpdateNewsService.com.
>
> For removal of your e-mail address, please click the "SafeUnsubscribe"
> link located in the footer of this message below to automatically
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>
> This email was sent to
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> Update Profile/Email Address |
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  1. 2005-11-02 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Massachusetts' CIO defends move to OpenDocument
  2. 2005-11-02 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] GNU/Linux Sysadmin Jobs for 60K
  3. 2005-11-02 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Sony Ships Sneaky DRM Software
  4. 2005-11-02 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] Sony Ships Sneaky DRM Software
  5. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Paris and Iraq
  6. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] Paris and Iraq
  7. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] Sony Ships Sneaky DRM Software
  8. 2005-11-03 Contrarian <adrba-at-nyct.net> Subject: [NYLXS - HANGOUT] Senate to vote today on M$ sponsored HB visas
  9. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: Still time to register: Tame the Data Explosion]
  10. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] More Sony DRM
  11. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Content Reading/Intel and GNU/Linux
  12. 2005-11-03 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: Linux Research - Request For Assistance]
  13. 2005-11-05 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: JobCircle Weekly Summary of New Jobs]
  14. 2005-11-07 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Community: Why Is Novell Chopping Its SUSE Linux Workstation and
  15. 2005-11-07 From: "Steve Milo" <slavik914-at-rennlist.net> Re: [NYLXS - HANGOUT] Community: Why Is Novell Chopping Its SUSE Linux Workstation and Desktop Product Line?
  16. 2005-11-08 From: <mlr52-at-michaellrichardson.com> Subject: [NYLXS - HANGOUT] Yahoo chat
  17. 2005-11-08 From: "J.E. Cripps" <cycmn-at-nyct.net> Re: [NYLXS - HANGOUT] Yahoo chat
  18. 2005-11-09 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [infsanto-at-council.nyc.ny.us: E-Update for the Committee on Technology in Government]
  19. 2005-11-09 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [smccool-at-realmsys.com: Linux Applications Contest ? Win $50K]
  20. 2005-11-10 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] New Worm Targets Linux Web Service Holes
  21. 2005-11-10 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Suse co-founder leaves Novell
  22. 2005-11-10 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Novell Tripping Over its Linux Strategy
  23. 2005-11-10 From: <mlr52-at-michaellrichardson.com> Re: [NYLXS - HANGOUT] New Worm Targets Linux Web Service Holes
  24. 2005-11-10 From: "Inker, Evan" <EInker-at-gam.com> RE: [NYLXS - HANGOUT] New Worm Targets Linux Web Service Holes
  25. 2005-11-10 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] General Membership Meeting Tuesday Night 11-15-2005
  26. 2005-11-10 From: "Inker, Evan" <EInker-at-gam.com> RE: [NYLXS - HANGOUT] General Membership Meeting Tuesday Night 11
  27. 2005-11-10 Ruben Safir <ruben-at-mrbrklyn.com> RE: [NYLXS - HANGOUT] General Membership Meeting Tuesday Night 11
  28. 2005-11-10 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] General Membership Meeting Tuesday Night
  29. 2005-11-10 From: <mlr52-at-michaellrichardson.com> RE: [NYLXS - HANGOUT] General Membership Meeting Tuesday Night 11-15-2005
  30. 2005-11-10 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Viruses exploit Sony DRM software
  31. 2005-11-10 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Even Better SONY's left and right hands
  32. 2005-11-11 From: "Inker, Evan" <EInker-at-gam.com> RE: [NYLXS - HANGOUT] Viruses exploit Sony DRM software
  33. 2005-11-11 From: "rc" <ray-pub-at-rcn.com> Subject: [NYLXS - HANGOUT] Monitors
  34. 2005-11-15 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] General Membership Meeting Thursday Night 11-17
  35. 2005-11-15 From: "Inker, Evan" <EInker-at-gam.com> RE: [NYLXS - HANGOUT] General Membership Meeting Tuesday Night 11
  36. 2005-11-15 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Europe and the US philosophically divided on open source?
  37. 2005-11-15 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Open source: Developing markets and anti-Americanism (Part 2)
  38. 2005-11-15 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: Press Release: Second Annual FDA Information Management
  39. 2005-11-15 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Suse 10.0 is Out!
  40. 2005-11-15 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Amy Harmon is at it again
  41. 2005-11-16 Contrarian <adrba-at-nyct.net> Re: [NYLXS - HANGOUT] Monitors
  42. 2005-11-16 Contrarian <adrba-at-nyct.net> Re: [NYLXS - HANGOUT] Amy Harmon is at it again
  43. 2005-11-16 From: <mlr52-at-michaellrichardson.com> Re: [NYLXS - HANGOUT] Suse 10.0 is Out!
  44. 2005-11-16 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] Sony pulls copy-protected CDs from shelves
  45. 2005-11-16 From: <mlr52-at-michaellrichardson.com> Re: [NYLXS - HANGOUT] Sony pulls copy-protected CDs from shelves
  46. 2005-11-16 Contrarian <adrba-at-nyct.net> Re: [NYLXS - HANGOUT] Monitors
  47. 2005-11-16 Mark Simko <msimko-at-optonline.net> Re: [NYLXS - HANGOUT] Monitors
  48. 2005-11-16 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Re: New to Linux
  49. 2005-11-16 From: "J.E. Cripps" <cycmn-at-nyct.net> Re: [NYLXS - HANGOUT] Monitors
  50. 2005-11-16 From: <mlr52-at-michaellrichardson.com> Re: [NYLXS - HANGOUT] Monitors
  51. 2005-11-18 From: "rc" <ray-pub-at-rcn.com> RE: [NYLXS - HANGOUT] Monitors
  52. 2005-11-18 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: E-Update for the Committee on Technology in Government -
  53. 2005-11-18 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: [nycsmalltalk] Presentation -- VisualWorks and algorithm
  54. 2005-11-20 Mark Simko <msimko-at-optonline.net> Subject: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging: Video
  55. 2005-11-20 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] [Fwd: JobCircle Weekly Summary of New Jobs]
  56. 2005-11-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging:
  57. 2005-11-20 From: "Steve Milo" <slavik914-at-rennlist.net> Re: [NYLXS - HANGOUT] [Fwd: JobCircle Weekly Summary of New Jobs]
  58. 2005-11-20 From: "Steve Milo" <slavik914-at-rennlist.net> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging: Video
  59. 2005-11-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] [Fwd: JobCircle Weekly Summary of New Jobs]
  60. 2005-11-20 Mark Simko <msimko-at-optonline.net> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging: Video
  61. 2005-11-20 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging:
  62. 2005-11-21 Contrarian <adrba-at-nyct.net> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging:
  63. 2005-11-21 Contrarian <adrba-at-nyct.net> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging:
  64. 2005-11-21 From: "Steve Milo" <slavik914-at-rennlist.net> Subject: [NYLXS - HANGOUT] =?utf-8?Q?Re:_[NYLXS_-_HANGOUT]_(Fwd)_Fwd:_Review_of_Compu?=
  65. 2005-11-21 Ruben Safir <ruben-at-mrbrklyn.com> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging:
  66. 2005-11-21 Contrarian <adrba-at-nyct.net> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging:
  67. 2005-11-21 From: <mlr52-at-mycouponmagic.com> Re: [NYLXS - HANGOUT] Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging: Video
  68. 2005-11-21 From: "Steve Milo" <slavik914-at-rennlist.net> Re: [NYLXS - HANGOUT] (Fwd) Fwd: Review of Computer Vote Rigging: Video
  69. 2005-11-22 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] General Membership Meeting Results
  70. 2005-11-22 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] That's Linux on the Line
  71. 2005-11-25 From: "Inker, Evan" <EInker-at-gam.com> Subject: [NYLXS - HANGOUT] FSF keeps pushing for Microsoft server protocols
  72. 2005-11-26 From: "rc" <ray-pub-at-rcn.com> RE: [NYLXS - HANGOUT] Suse 10.0 is Out!
  73. 2005-11-28 Ruben Safir <ruben-at-mrbrklyn.com> Subject: [NYLXS - HANGOUT] Jobs
  74. 2005-11-30 From: "rc" <ray-pub-at-rcn.com> RE: [NYLXS - HANGOUT] Suse 10.0 is Out!
  75. 2005-11-30 Contrarian <adrba-at-nyct.net> Subject: [NYLXS - HANGOUT] Second anti-DRM demonstration today

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