This webinar 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.
Live Webinar on Excel Spreadsheet Validation for FDA 21 CFR Part 11 Course "Excel Spreadsheet Validation for FDA 21 CFR Part 11" has been pre-approved by RAPS as eligible for up to 1.5 credits Register Now towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: Thursday, June 14, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: Angela Bazigos Angela Bazigos CEO, Touchstone Location: Online Price : $245.00 (for one participant) Technologies Silicon Valley Angela Bazigos is the CEO of Overview: Touchstone Technologies Silicon This webinar will describe the regulatory and business requirements Valley, Inc. an FDA Compliance for Excel spreadsheets, using examples from FDA recommendations. company. She has almost 30 years It will then cover the design and installation of those Excel experience in the Lifesciences Spreadsheets, to ensure the integrity of the data, and will discuss industry and has applied for patents aimed at speeding up Software how to ensure 21 CFR 11 compliance during the development, Compliance. She is a member of the installation and maintenance of a spreadsheet application. SQA CVIC (Society of Quality Assurance Computer Validation Why should you attend: Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Spreadsheet Applications such as MS Excel are frequently used in 21 Computer Systems Validation, CFR 11 compliant environments, but they were not specifically Compliance Strategy and Project designed for regulated environments and their development is not Management. More recently, Ms. optimized for 21 CFR 11 compliance. However, the FDA expects that Bazigos was selected to co-author spreadsheets be compliant and lack of compliance can result in a Computerized Systems In Clinical warning letter. Consequently, validation of Excel Spreadsheet Research / Current Data Quality and Data Integrity Concepts with FDA, Applications is required as part of a 21 CFR 11 compliant DIA and Academia. ...more environment. Areas Covered in the Session: Suggest a Topic More Webinars l Requirements for Excel Spreadsheets Your Necessity is our Priority l FDA Part 11 Validation Guidance l Compliance Problems with Spreadsheets l Design Specifications for 21 CFR 11 compliance l How does the FDA Design and Use spreadsheets l Documentation for Part 11 l Future Trends in 21 CFR 11 compliance for Excel Spreadsheets Click here to register for this webinar Who Will Benefit: l Quality Managers l Quality Engineers l Small business owners l Internal and external auditors l Management Reps l FDA inspectors l Consultants It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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