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RAPS Approved Webinar

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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 eligible for up to 1.25 credits towards a participant's RAC

 

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recertification upon full completion. Instructor Profile: Tuesday, August 28, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Dr. Ludwig Huber

Location: Online

Price : $245.00

Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies

(for one participant)

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. ...more

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. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel®  capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations.

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Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley. Recommendations from the new GAMP®5 and EU Annex 11 How to design spreadsheets for compliance. How to ensure and validate spreadsheet integrity.

When, what and how much to test? Validation of standard/native Excel functions? How to apply risk based validation to spreadsheet applications Validation of 'ad hoc' spreadsheet applications. How to document planning, specifications, installation, testing and changes Examples from manufacturing, laboratories and offices

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Everybody developing and using Excel Worksheets for regulated environments QA managers and personnel QC managers and personnel IT managers and personnel Analysts and lab managers Validation groups Validation professionals Training departments Documentation department 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  

Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and repor...

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