Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance
Thursday, October 13, 2016 from 10:00 AM to 11:15 AM (PDT)
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. His wide knowledge on these subjects comes from his involvement in the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 230 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.
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.