Training Course Syllabus:

Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance

Why Should you Attend

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.

Areas Covered

Review current enforcement posture towards spreadsheets
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

Who will Benefit

This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include: System owners - responsible for keeping individual systems in validation, QA / QC managers, executives and personnel, IT / IS managers and personnel, Validation engineers, validation specialists, Software quality reviewers, software quality reviewers, SQA, Consultants, Quality Engineers (QE)Production and Process Engineers, Manufacturing Engineers, Design Engineers, Purchasing Managers, Purchasing Agents, Supplier Quality Engineers, Quality Supervisors, Quality Inspectors, Quality Managers, Quality Audit Managers, Quality Auditors

Seminar Summary:

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. (see full course description)

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