This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
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 in the Webinar:
- Review of current FDA posture towards spreadsheets.
- Review the relationship between 'validation' and 'part 11 compliance'.
- How do I determine which spreadsheets require validation?
- Which spreadsheets are required to be compliant to 21 CFR Part 11 regulation?
- Technical issues discussion.
- Practical tips on gaining control over spreadsheets.
- Practical tips on spreadsheet validation.
Who Will Benefit:
Companies that manufacture, sell, or distribute Pharmaceuticals, Medical Devices, Biologics will benefit from this webinar, as well as vendors and suppliers who support them. Personnel who will benefit include:- Management responsible for operational and quality systems ('system owners')
- Quality VPs, QA/QC Directors, Managers and personnel
- IT/IS managers and personnel
- Software validation and Software quality managers + personnel
- Quality auditors and consultants charged with creating or evaluating validation and part 11 programs
- Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
- All business personnel who use spreadhseets that are subject to regulation
Course Provider
Alfonso Fuller,
