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.
Most organizations lack a clear spreadsheet compliance strategy. An unplanned 'emergency' spreadsheet validation project could paralyze the organization. This webinar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.
Learning Objectives:
- Understand the significance of spreadsheets as software as viewed by US FDA
- Review current FDA posture towards spreadsheets
- Know how to conduct an audit of the use of spreadsheets in the organization
- Recognize when spreadsheets being used should conform to FDA regulations
- Be able to determine which spreadsheets are not required to be validated, and how to document
- Be able to determine which spreadsheets do not trigger 21 CFR part 11 compliance
- Know the relationship between spreadsheets and SDLC
- Review the relationship between "validation" and "part 11 compliance"
- Be able to plan spreadsheet validations, and integrate into overall validation planning
Why Should You Attend:
Spreadsheets are powerful business tools and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.
Topics
- Review current enforcement posture towards spreadsheets
- Review the relationship between "validation" and "part 11 compliance"
- Determining which spreadsheets require validation - and which don't
- Which spreadsheets are required to be compliant to 21 CFR Part 11
- Technical issues discussion
- Practical tips on gaining control over spreadsheets
- Practical tips on spreadsheet validation
Instructor
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers.
He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.