3-Hour Virtual Seminar on Excel Spreadsheet Validation for FDA 21 CFR Part 11
In this Interactive session speaker will explain validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment, and Requirements for Excel Spreadsheets.
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
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. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.
Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.
Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.