Excel Spreadsheet Validation for FDA 21 CFR Part 11

Overview:

Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

Why should you Attend: Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This bootcamp will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

Areas Covered in the Session:

• Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)
• Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)
• Examples of Typical Approaches for Excel Validation
• How to tailor your risk based methodology to Excel to determine the level of validation required

Who Will Benefit:

• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors /Senior Directors of Discovery
• Directors /Senior Directors of Development
• Directors /Senior Directors of Commercialization
• Document Managers
• Training Managers
• Regulators

Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.