Spreadsheet Validation:
Tools and Techniques to Meet FDA Requirements
“He [David Harrison] gave good information on the process, the 'whos, whats and whys' of the process. This was insightful and easy to follow."
Christa Ford
Quality Assurance Manager
Sciona, Inc.
Back by popular demand — and even better than before! This audioconference made such a difference that drug and device companies asked for another chance to train staff who use and validate spreadsheets. We decided to not only offer it again, but to run it as a webinar.
Updated and enhanced, you can hear what steps and strategies top validation expert David Harrison recommends to help you "bulletproof" your compliance programs.
Spreadsheet validation can close the compliance gap before you face high-profile FDA warnings and high-stakes liabilities. Do you know how to implement validation on your own spreadsheets? How to make sure you're meeting FDA expectations? And how to turn that large spreadsheet inventory around with minimum effort and minimal resources?
You’ll hear as David shares examples, manipulates cells and provides tips and tricks to streamline your spreadsheet validation process.
Step by step, he’ll walk you through his own spreadsheet to demonstrate what functionality needs to be validated and what security controls need to be put into place. Plus, David will provide examples of third-party software features that improve security and audit trail capabilities within Microsoft® Excel spreadsheets.
Hear firsthand how to develop a spreadsheet that closes the gaps the FDA is after!
Order now for your entire team to listen and discover:
- Exactly what the FDA looks for and why, including examples of noncompliance and regulatory concerns
- Sources of FDA publications on spreadsheet use and validation
- What spreadsheet "gaps" the FDA is targeting
- Today's best practices and options for validating spreadsheets
- How to choose an approach for efficient and repeatable validation
- How to fit spreadsheet validation into your traditional QA and validation processes
- How to generate spreadsheet specifications
- What to include in spreadsheet qualifications
- How to test spreadsheets and macros
- How to plan, manage and resource an effective project
Plus, you’ll hear examples of documentation contents and test scripts used during validation.
David Harrison is a principal consultant with ABB Engineering Services who specializes in pharmaceutical compliance and validation. He is currently the product manager for the ABB Excel Validation Solution and is responsible for managing the company's product and support services worldwide. His previous roles at ABB were in the introduction and implementation of 21 CFR Part 11 and computerized system validation projects and initiatives for key blue-chip pharmaceutical clients. Prior to joining ABB, David worked in various quality assurance roles within the drug and biotech industry in both the UK and the U.S.
- Auditors
- Clinical QA/QC specialists
- Clinical research associates
- Compliance officers
- Data management and statistics personnel
- Financial accountants and auditors (SOX404)
- Managers
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- R&D staff
- Study monitors
- Study research coordinators
- Validation specialists, scientists and engineers
- AND any compliance professional who uses Microsoft® Excel spreadsheets
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600