[Hardhats-members] [Fwd: Press Release: Second Annual FDA Information Management Summit Nov. 30 - Dec. 3, 2005]
-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 RD 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
Re: [Hardhats-members] [Fwd: Press Release: Second Annual FDA Information Management Summit Nov. 30 - Dec. 3, 2005]
Oh joy. On Tuesday 15 November 2005 04:34 pm, Ruben Safir wrote: -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 RD 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
Re: [Hardhats-members] [Fwd: Press Release: Second Annual FDA Information Management Summit Nov. 30 - Dec. 3, 2005]
Surely you are not surprised.Nancy Anthracite [EMAIL PROTECTED] wrote: Oh joy. ===Gregory Woodhouse [EMAIL PROTECTED] "Einstein was a giant. He had his head in the clouds and his feet on the ground." -- Richard P. Feynman
Re: [Hardhats-members] [Fwd: Press Release: Second Annual FDA Information Management Summit Nov. 30 - Dec. 3, 2005]
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. No problemone can always switch back to paper... ;-) --- This SF.Net email is sponsored by the JBoss Inc. Get Certified Today Register for a JBoss Training Course. Free Certification Exam for All Training Attendees Through End of 2005. For more info visit: http://ads.osdn.com/?ad_id=7628alloc_id=16845op=click ___ Hardhats-members mailing list Hardhats-members@lists.sourceforge.net https://lists.sourceforge.net/lists/listinfo/hardhats-members
