Excel Spreadsheets - Ensuring Data Integrity and 21 CFR Part 11 Compliance
- Training Type Recorded Webinar
- Presenter Carolyn Troiano
- Topic Pharmaceutical
- Schedule Jul 14, 2023
- Timing 1:00 PM EST
- Duration 90 minutes
Description
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
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.
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.
Who Should Attend:-
This session will benefit for:
- Computer system users
- IT personnel
- QA personnel
- Managers
- Executives
Speaker
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDAs electronic record/electronic signature regulation.