Excel Spreadsheets for 21 CFR 11 Compliance
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Website https://www.traininng.com/webinar/excel-spreadsheets-for-21-cfr-11-compliance-200431live?ourglocal-D |
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Category Quality Managers, Quality Engineers, Small Business Owners
Deadline: December 10, 2018 | Date: December 12, 2018
Venue/Country: Online, U.S.A
Updated: 2018-11-13 17:56:54 (GMT+9)
Call For Papers - CFP
OverviewSpreadsheet 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 SessionRequirements for Excel SpreadsheetsFDA Part 11 Validation GuidanceCompliance Problems with SpreadsheetsDesign Specifications for 21 CFR 11 complianceDocumentation for Part 11Future Trends in 21 CFR 11 compliance for Excel SpreadsheetsWho Will BenefitQuality ManagersQuality EngineersSmall Business OwnersGxPConsultantsQuality VPsIT VPsSpeaker ProfileAngela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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