Validation of Excel Spreadsheets for Regulated Environments: Step-by-Step

Duration: 75 Minutes
In this webinar on validation of excel spreadsheets, the participants will learn how to apply risk based validation to spreadsheet applications step-by-step. The webinar will also discuss what are the requirements for excel validation and how to implement them to comply with the regulations.
Excel Validation
Instructor: Dr. Ludwig Huber
Product ID: 501188
Objectives of the Presentation
  • Regulatory requirements for spreadsheets FDA Part 11, GxP
  • Recommendations from the new GAMP 5 and Annex 11
  • Developing a validation policy and plan
  • Setting user requirement specifications: The right level of detail
  • When, what and how much to test
  • Writing a test plan
  • How to document test results
  • 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
  • Going through a complete example from beginning to end
Why Should you Attend
Excel Applications are widely used in laboratories, offices and manufacturing for data capture, data manipulation and report generation. Like any other software, Excel spreadsheets must be validated when used in regulated environment. However, while the validation of vendor supplied software applications is well understood and performed by validation professionals, this is not the case with spreadsheet applications. Frequently they are developed by members of the department or by users, who may not be validation experts, so attend this webinar to clarify all your validation related queries.

Who can Benefit
  • Laboratory managers and supervisors
  • Quality Assurance Managers
  • Develops of spreadsheet applications
  • All users of Excel used in regulated environments
  • QA managers and personnel
  • GMP auditors
  • Consultants
$375
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ludwig Huber, Ph.D., is the director of Lab compliance, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world.


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