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 |