This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
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 and compliant to 21 CFR Part 11 in some cases. This presentation explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.
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")
- QA Directors, Managers and personnel
- IT / IS managers and personnel
- Software validation and Software quality managers + personnel
- Programmers, developers, project managers and others responsible for bringing systems online in a compliant manner
- Quality auditors responsible for auditing and evaluating part 11 compliance
- All business personnel who use spreadhseets that are subject to regulation.
Instructor Profile:
Alfonso Fuller, JD, is the founder and President of Fuller Compliance, LLC, a consulting firm that specializes in FDA quality system, software quality and software validation for pharmaceutical, biotech and medical device companies. Al is the author of numerous white papers, has spoken at numerous seminars, and has represented many clients before FDA compliance and enforcement personnel.
