VIEWS: 119 PAGES: 2 CATEGORY: Healthcare & Medicine POSTED ON: 7/6/2012
Overview: Excel� Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.
RAPS Approved Webinar on Validation and Use of Excel® Spreadsheets in Regulated Environments Date & Time: Course "Validation and Use of Excel® Spreadsheets in Regulated Environments" has been pre-approved by RAPS as Register Now eligible for up to 1.25 credits towards a participant's RAC recertification upon full completion. Instructor Profile: Tuesday, August 28, 2012 10:00 AM PDT | 01:00 PM EDT Dr. Ludwig Huber Duration: 75 Minutes Instructor: Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Location: Online Price : $245.00 (for one participant) Technologies Ludwig Huber, Ph.D., is Director of Overview: Labcompliance and Chief Advisor for Excel® Applications are widely used in laboratories, offices and global FDA compliance at Agilent manufacturing e.g., for data capture, data manipulation and report Technologies. He is the editor of generation. Regulations such as HIPAA, Sarbanes Oxley Act and Labcompliance, the global on-line resource for validation and FDA's GxP and 21 CFR Part 11 require users of software and compliance issues for laboratories. computer systems to demonstrate and document data accuracy, He is the author of the books integrity and confidentiality. "Validation and Qualification in Analytical Laboratories, and Out-of-the box Excel® has not been designed for regulated "Validation of Computerized environments. However, with a good knowledge of Excel® Analytical and Networked Systems", capabilities combined with good procedures and practices on how to Informa Healthcare. ...more validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations. Suggest a Topic More Webinars Areas Covered in the Session: Your Necessity is our Priority l Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley. l Recommendations from the new GAMP®5 and EU Annex 11 l How to design spreadsheets for compliance. l How to ensure and validate spreadsheet integrity. l When, what and how much to test? l Validation of standard/native Excel functions? l How to apply risk based validation to spreadsheet applications l Validation of 'ad hoc' spreadsheet applications. l How to document planning, specifications, installation, testing and changes l Examples from manufacturing, laboratories and offices Click here to register for this webinar Who Will Benefit: l Everybody developing and using Excel Worksheets for regulated environments l QA managers and personnel l QC managers and personnel l IT managers and personnel l Analysts and lab managers l Validation groups l Validation professionals l Training departments l Documentation department l Consultants 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 GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel 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.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 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
"Validation and Use of Excel� Spreadsheets in Regulated Environments - Webinar By GlobalCompliancePanel"