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


 Available : All Days  Presented By : David Nettleton
 Category : Pharmaceutical  Event Type : Recorded Webinar

For group or any booking support, contact:  cs@educationsgrow.com  + 1 (844) 240-7679 (US Toll Free)

Recording $179
Transcript $179
DVD $189
Flash Drive $199
Recording & Transcript $359

Description

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

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.

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.

Who Will Benefit:-

This session will benefit:

  • Computer system users
  • IT personnel
  • QA personnel
  • Managers
  • Executives

Presented By : David Nettleton

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.

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