Spreadsheet Validation: Understanding and satisfying FDA requirements (FDA Validation)
Venue: Online Event
|Event Date/Time: Aug 08, 2012||End Date/Time: Aug 08, 2012|
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 seminar:
- 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