Validation and use of Excel spreadsheets in FDA regulated environments

Why Should You Attend

• FDA expressly regulates spreadsheets.
• FDA inspectors are specifically trained to look for and at spreadsheets.
• Spreadsheet use is widespread throughout most organizations.
• Most organizations lack a clear spreadsheet compliance strategy.
• An unplanned 'emergency' spreadsheet validation proejct could paralyze the organization.

Many companies struggle with spreadsheet compliance. Some are still using invalidated spreadsheets. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to spreadsheets. This seminar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.

Areas Covered in the seminar:

• Outline of FDA regulations as applied to software in general.
• Review of FDA software validation requirements as applied to spreadsheets.
• What's in it for you to validate spreadsheets.
• Common technical issues with Excel spreadsheets.
• Common resolutions to technical issues.
• Review of spreadsheet usage in FDA regulated environments.

Who will benefit:

This seminar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:

• System owners and personnel who create or use spreadsheets in FDA regulated areas
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

Instructor Profile:

Alfonso Fuller, is the founder and President of Fuller Compliance, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of several white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel, and actively consults on day-to-day compliance issues.