Event Detail
21 CFR Part 11 Compliance for Excel Spreadsheets - Webinar By GlobalCompliancePanel
October 2, 2012 - Wilmington DE US
GlobalCompliancePanel
webinars@globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Overview: 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 environment. Areas Covered in the Session: Requirements for Excel Spreadsheets FDA Part 11 Validation Guidance Compliance Problems with Spreadsheets Design Specifications for 21 CFR 11 compliance Documentation for Part 11 Future Trends in 21 CFR 11 compliance for Excel Spreadsheets Who Will Benefit: Quality Managers Quality Engineers Small business owners GxP Consultants Quality VPs IT VPs Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years experience in the Lifescience industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent 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 consults to many Pharma / Biotech / Medical Device and CRO’s on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Lifescience industry. Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world. Webinar By GlobalCompliancePanel Price List: Live : $245.00 Corporate live : $495.00 Recorded : $295.00 Phone: 800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com 1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801