Avoid FDA Enforcement: Configure and Validate Your Excel Spreadsheets to Prevent 483s| ARCHIVE | Nettleton
April 14th, 2011 // 8:47 am @ jmpickett
Learn how to configure and validate Excel applications to avoid 483s. This interactive webinar presents step-by-step instructions followed by a hands-on Excel workshop where each participant follows along with a live demonstration. You will become a better Excel user, saving you time and costs, while advancing compliance.
Archive Recording – Download Webinar the Same Day (CD also available at no extra cost)
Price: $349
NOTE: 45-minute Powerpoint Webinar is followed by a 30-minute, live step-by-step Excel workshop
Objectives:
- 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.
- Configure Excel for audit trails, security features, data verification, and multiple concurrent users.
- Avoid 483s and warning letters.
- Understand what does and does not need to be validated.
- Validate your application with minimal documentation.
Target Audience:
- All Excel users
- Laboratory staff
- QC
- QA
- IT
- Managers
- Executives
- Attendees will receive these free gifts:
- Subscription to FDA Digest – 483/warning letter e-newsletter
- Six-month subscription to SMARTERCOMPLIANCEâ„¢ newsletter by Cerulean Associates ($129 value)
- Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
- “Lean Compliance for Midsized Companiesâ€Â (from Journal of GXP Compliance, January 2008)
About the 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 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.
Archive Recording – Download Webinar the Same Day (CD also available at no extra cost)
Price: $349
