This interactive webinar explains how to configure and validate a GxP compliant spreadsheet application to avoid FDA 483s. It has a detailed presentation and live Excel demonstration followed by an interactive workshop. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Learning Objectives:

· Develop spreadsheet applications that are GxP compliant.

· Avoid 483s and warning letters.

· Understand what does and does not need to be validated.

· Learn how to use Excel’s built in 21 CFR Part 11 features.

· Apply features required for GxP environments without programming macros.

· Validate your application with minimal documentation.

· Configure Excel for audit trails, security features, data verification, and multiple concurrent users.

Who is the Target Audience:

All Excel users
IT
QA
QC
Laboratory staff
Managers
Executives

About Speaker

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 206 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.