This webinar will discuss how to ensure Excel spreadsheets comply with 21 CFR Part 11 requirements for electronic records and electronic signatures. It will cover FDA recommendations for spreadsheet design, development, and maintenance. Attendees will learn how to validate Excel applications, document requirements, and future compliance trends. The webinar leader Angela Bazigos has nearly 30 years of life sciences experience helping companies achieve regulatory compliance.

1. Live Webinar on : Excel Spreadsheet Compliance with 21CFR11 Thursday, October 20, 2011duration : 01:00 to 02:30 PM EST Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15 Who will benefit Compliance directorCEOCFOPrivacy OfficerSecurity OfficerInformation Systems ManagerHIPAA OfficerChief Information OfficerHealth Information ManagerHealthcare Counsel/lawyerOffice ManagerContracts ManagerPricingLive ( Single registration ) : $189.00Group ( Max 10 Attendee): $499.00More Trainings 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 optimized 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 environments. Areas Covered in the Seminar: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 SpreadsheetsAbout Speaker:Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Life sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academiahttps://compliance2go.com/index.php?option=com_training&speakerkey=13&productKey=28Compliance2go | www.Compliance2go.com Phone : 877.782.4696 | Fax : 281-971-0286 Email : Support@compliance2go.com<br />