21CFR 11 Compliance for Excel Spreadsheet
View: 110
Website https://compliance2go.com/product/?pid=CP2014-363 |
Edit Freely
Category Medical Device
Deadline: September 18, 2014 | Date: September 18, 2014
Venue/Country: Houston, U.S.A
Updated: 2014-08-27 18:00:15 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Why should you attend:Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimised for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.Areas Covered in the Session:1. Requirements for Excel Spreadsheets2. FDA Part 11 Validation Guidance3. Compliance Problems with Spreadsheets4. Design Specifications for 21 CFR 11 compliance5. How does the FDA Design and Use spreadsheets6. Documentation for Part 117. Future Trends in 21 CFR 11 compliance for Excel SpreadsheetsWho will benefit: Quality ManagersQuality EngineersSmall business ownersInternal and external auditorsManagement RepsFDA inspectorsConsultantsWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.