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Recorded WebinarNew

Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance

Avoid FDA 483s by properly configuring GxP-compliant Excel spreadsheets — step-by-step setup of audit trails, security features, Part 11 compliance, and minimal-documentation validation.

4.8(0 reviews)
1.25 hours
David Nettleton

Instructor

David Nettleton

FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation

What You'll Learn

How to develop GxP-compliant spreadsheet applications
Using Excel's built-in 21 CFR Part 11 features without macros
Configuring Excel for audit trails, security features, and data entry verification
Applying cell and file protections in regulated multi-user environments
Reducing validation time and costs with minimal documentation
Understanding what does and does not need to be validated

About This Event

This interactive webinar by industry expert David Nettleton explains how to avoid FDA 483s by proper configuration and validation of GxP-compliant spreadsheet applications. Follow step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a good understanding of how to validate your application with minimal documentation. It is advised to bring your laptop and use Excel for your own needs. This session will help you save time and cost and make you a superior Excel user. Code: FDB3451

Curriculum

Excel's Built-in 21 CFR Part 11 Features
15 min
Configuring Audit Trails, Security, and Data Entry Verification
15 min
Cell and File Protections for Regulated Use
10 min

Requirements

  • All Excel users in regulated environments — QA, QC, IT, Laboratory Staff
  • Applicable to managers and executives in pharmaceutical, medical device, and biotech industries

Meet Your Instructor

David Nettleton

David Nettleton

FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation

David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation — Ten Easy Steps", relating to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.

21 CFR Part 11 Specialist185+ Validation ProjectsHIPAA Compliance ExpertPublished Author
Quantity
1

Recording – 1 Viewer

$299.00
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Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.25 hours

Certificate

Included

Access

Lifetime

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