Spreadsheet Validation
Latest Regulatory Developments and Best Practices

Wednesday, Jan. 22, 2020 • 1:30 p.m. - 3:00 p.m. EST

Perch on the shoulder of a spreadsheet validation expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences in real time.

Mark your calendar for Wednesday, Jan. 22, when compliance expert David Harrison supplies the answers — and more.

Mr. Harrison, a principal consultant with CSV Compliance Ltd., has shepherded more than 400 spreadsheet validation projects for life science clients like you. He’ll discuss the best practices and available options for validating spreadsheets.

Webinar Takeaways:

  • Discuss FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820 
  • Determine spreadsheet validation gaps the FDA targets
  • Choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes
  • Generate spreadsheet specifications and qualification protocols
  • Test spreadsheets and macros
  • Plan, manage and resource an effective project

Drug and biotech firms, devicemakers, clinical trial operators — every regulated life science firm relies on Excel spreadsheets that must pass FDA muster. Close the compliance gap before you face FDA warnings and liabilities. Join us by registering today.

Who Will Benefit

This presentation is aimed at all compliance professionals who use Excel spreadsheets. Specific job titles include:

  • QA/QC
  • Validation specialists and engineers
  • Clinical research
  • Compliance
  • Data management and statistics
  • Rx and cGMP auditors
  • R&D
  • Study monitors/coordinators
  • Financial accountants/auditors (SOX404)

Webinar plus USB Audio Recording/Transcript
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$487

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Webinar only
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$287

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24/7 Encore plus USB Audio Recording/Transcript
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$487

add to cart

24/7 Encore Presentation
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$287

add to cart

USB Audio Recording/Transcript
Learn more

$287

add to cart

 

Meet Your Presenter

David Harrison

Principal Consultant
CSV Compliance Limited

David Harrison is a principal consultant with CSV Compliance Limited where he specializes in life sciences compliance and computer system validation. He has managed the introduction and implementation of 21 CFR Part 11 and system validation projects for many blue-chip clients and shepherded more than 400 spreadsheet validation projects.

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