Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance

	"Course Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion."

Why Should You Attend:
Learn how to create an Excel spreadsheet application that is GxP compliant. Understand how to validate your application with minimal documentation. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. This session includes an interactive workshop so you can learn techniques that are important to you. Bring your laptop and use Excel for your own needs.

Areas Covered in the Seminar:

• Avoid 483s and Warning Letters.
• Become compliance 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
• QA
• Managers
• Executives

Instructor Profile:
David Nettleton, 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 200 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project.