Training Course Syllabus:

Objectives of the Presentation

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.

Areas Covered

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

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, 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:

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. (see full course description)

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