Spreadsheet Validation 2017 - Webinar CD/Transcript
Spreadsheet Validation 2017: Tools and Techniques to Meet FDA Requirements
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback?
What if you could discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval?
Well, you can.
Join trusted spreadsheet validation expert David Harrison for a 90-minute session when he’ll discuss the best practices and available options for validating spreadsheets, including:
- Exactly what the FDA looks for and why, including examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820
- Spreadsheet validation "gaps" the FDA is targeting
- Assess data integrity concerns within spreadsheets and consider the use of Excel for audit trail reviews
- How to choose an approach for efficient and repeatable validation which fits into your traditional QA and validation processes
- How to generate spreadsheet specifications and qualification protocols
- How to test spreadsheets and macros
- How to plan, manage and resource an effective project
- Sources of FDA publications on spreadsheet use and validation
Order today and close the compliance gap before you face FDA warnings and liabilities.