Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Join us for a webinar on November 04 for a discussion of the webinar

Who Will Benefit

  • All Excel users
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • Executives

Webinar Takeaways

  • Develop spreadsheet applications that are GxP compliant
  • Learn how to use Excel’s built in 21 CFR Part 11 features
  • Apply features required for GxP environments without programming macros.
  • Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users
  • Validate your application with minimal documentation
  • Understand what does and does not need to be validated.
  • How to specify and test your application
  • Avoid 483s and Warning Letters
  • How to use cell and file protections
  • Reduce validation time and costs
  • Increase compliance while lowering resource needs

Overview

which explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. David Nettleton will make you understand how to validate your application with minimal documentation. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Faculty David Nettleton

Faculty David Nettleton

Owner, Computer System Validation and FDA Compliance consultant. 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.

Choose a Purchase Options

$199

Live Webinar - Single Participant 90-mins

You get one log-in for the live 90-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email

$399

Group Up to 5 Participants

You get 5 log-in for the live 90-minute webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email