Sign for Notice Everyday    Sign Up| Sign In| Link| English|

Our Sponsors

    Receive Latest News

    Feedburner
    Share Us


    21CFR 11 Compliance for Excel Spreadsheet

    View: 218

    Website https://compliance2go.com/product/?pid=CP2014-363 | Want to Edit it Edit Freely

    Category Biotechnology , Medical Device , Pharmaceutical

    Deadline: September 18, 2014 | Date: September 18, 2014

    Venue/Country: Houston, U.S.A

    Updated: 2014-08-22 19:34:33 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    This 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 Spreadsheets

    2. FDA Part 11 Validation Guidance

    3. Compliance Problems with Spreadsheets

    4. Design Specifications for 21 CFR 11 compliance

    5. How does the FDA Design and Use spreadsheets

    6. Documentation for Part 11

    7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

    Who will benefit:

    Quality Managers

    Quality Engineers

    Small business owners

    Internal and external auditors

    Management Reps

    FDA inspectors

    Consultants

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate 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.