Learning from Recent FDA Warning Letters - Webinar by GlobalCompliancePanel

  Live WebinarLearning from Recent FDA Warning Letters Related to Computer   Validation and Part 11 - Prepare Yourself for the upcoming FDA Part 11 InspectionsDate:Thursday, September 09, 2010Time:10:00 AM PDT | 01:00 PM EDTRegister Now Duration:75 MinutesPrice:$245.00Overview:On July 8, 2010, the FDA announced to soon conduct a series of Instructor Profile:inspections related to 21 CFR Part 11. FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the Dr. Ludwig HuberChief Advisor - Global FDA issues are is to look at recent FDA 483 form inspectional compliance, Agilent observations and warning letters related to computer system Technologies validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with Ludwig Huber, Ph.D., is Director of disastrous consequences for inspected companies. This seminar will Labcompliance and Chief Advisor for give an overview of FDA inspection findings and recommendations global FDA compliance at Agilent on how to avoid them. Technologies. He is the editor of Labcompliance, the global on-line Areas Covered in the Session: resource for validation and compliance issues for laboratories. lFDA inspections: Preparation, conducts, follow upHe is the author of the books lThe meaning of warning letters and 483 inspectional "Validation and Qualification in observationsAnalytical Laboratories, and lLearning from an FDA presentation: "Data Integrity and Fraud - "Validation of Computerized Another Looming Crisis?"Analytical and Networked Systems",  Informa Healthcare. ...morelData integrity and authenticity: FDA's new focus during  inspections of computer systems and e-records lExamples of recent Part 11 related 483's and Warning LetterslExamples of recent 483' and warning letters related to computer Suggest a TopicMore Webinarssystem validation ‘ Your Necessity is our PrioritylMost obvious reasons for deviationslResponding to 483's to avoid warning letters: going through case studieslWriting corrective and preventive action plans as follow up to 483'slStrategies and tools for compliant Part 11 implementationlFDA's Part 11 Inspection Initiative 2010Click here to register for this webinarWho Will Benefit: lIT managers and system administratorslPart 11 Project ManagerslQA Managers and Personnel lAnalysts and Lab ManagerslSoftware DeveloperslValidation ProfessionalslTraining DepartmentslDocumentation DepartmentlConsultants It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program.For more information, please contact the event coordinator. We look forward to seeing you at the webinar.Best regards,Event-coordinator GlobalCompliancePanelAbout GlobalCompliancePanelGlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals.GlobalCompliancePanel www.globalcompliancepanel.com1000 N West Street Suite, 1200 Wilmington DE 19801Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe