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Excel Spreadsheets - Step-By-Step Instructions for Compliance

2 December 2014, Fremont, United States


Introduction
Areas Covered in the Session:
Develop spreadsheet applications that are GxP compliant.
Avoid 483s and warning letters. Critical data, such as laboratory information and other GxP data, is often recorded in spreadsheet applications and are subject to regulatory inspection.
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.
Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.

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Speakers
  • 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" that relates 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., United States

Venue
Online Webinar

Online Webinar, 161 Mission Falls Lane, Suite 216, Fremont, 94539, United States

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