-----Forwarded Message----- > From: Pharma Update News Service <[EMAIL PROTECTED]> > To: [EMAIL PROTECTED] > 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: > [EMAIL PROTECTED] > > For removal of your e-mail address, please click the "SafeUnsubscribe" > link located in the footer of this message below to automatically > remove your address from the list. > > This email was sent to > [EMAIL PROTECTED], by > [EMAIL PROTECTED] > Update Profile/Email Address | > Instant removal with > SafeUnsubscribe™ | Privacy Policy. > Powered by > > > FDAnews | 300 N. 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