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Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Why Should You Attend:
This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data.
Areas Covered in the Webinar:
- Avoid 483s and Warning Letters.
- Ensure compliance with 21 CFR Part 11 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 personnel
- QA personnel
Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 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 250 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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GAMP® Validation Protocols for Efficient Documentation 10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11 21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s