Product Details
Perch on the shoulder of a spreadsheet validation expert to discover potential pitfalls and innovative approaches. Get feedback, resolve pain points and share experiences.
Compliance expert David Harrison supplies the answers — and more.
Mr. Harrison, a principal consultant with CSV Compliance Ltd., has shepherded more than 400 spreadsheet validation projects for life science clients like you. He’ll discuss the best practices and available options for validating spreadsheets.
Presentation Takeaways:
- Discuss FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820
- Determine spreadsheet validation gaps the FDA targets
- Choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes
- Generate spreadsheet specifications and qualification protocols
- Test spreadsheets and macros
- Plan, manage and resource an effective project
Drug and biotech firms, devicemakers, clinical trial operators — every regulated life science firm relies on Excel spreadsheets that must pass FDA muster. Close the compliance gap before you face FDA warnings and liabilities.
Meet Your Presenter
David Harrison is a principal consultant with CSV Compliance Limited where he specializes in life sciences compliance and computer system validation. He has managed the introduction and implementation of 21 CFR Part 11 and system validation projects for many blue-chip clients and shepherded more than 400 spreadsheet validation projects.
Who Will Benefit
This presentation is aimed at all compliance professionals who use Excel spreadsheets. Specific job titles include:
- QA/QC
- Validation specialists and engineers
- Clinical research
- Compliance
- Data management and statistics
- Rx and cGMP auditors
- R&D
- Study monitors/coordinators
- Financial accountants/auditors (SOX404)