RAPS Approved Webinar
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
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
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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Areas Covered in the Session:
Your Necessity is our Priority
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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
Click here to register for this webinar Who Will Benefit: l
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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
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Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and repor...