ComplianceOnline

Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance

Instructor: David Nettleton
Product ID: 701582
  • 7
  • February 2017
    Tuesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 75 Min

Live Online Training
February 07, Tuesday 10:00 AM PST | 01:00 PM EST
Duration: 75 Min

$229.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

Why Should You Attend:

This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data.

Areas Covered in the Webinar:

  • Avoid 483s and Warning Letters.
  • Ensure compliance with 21 CFR Part 11 when using Excel spreadsheets for GxP data.
  • How to use cell and file protections.
  • How to use Excel’s audit trail.
  • Reduce validation time and costs.
  • Increase compliance while lowering resource needs.
  • Understand what validation documentation is required.
  • Hands-on workshop to address your specific needs.

Who Will Benefit:

This session will benefit for:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives
Instructor Profile:
David Nettleton

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

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