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      Excel Spreadsheet Validation for FDA 21 CFR Part 11 in Fremont


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      January 16, 2019

      Wednesday   9:00 AM - 12:00 PM

      Fremont, California, United States
      Fremont, California

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      EVENT DETAILS
      Excel Spreadsheet Validation for FDA 21 CFR Part 11

      Overview
      Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

      Why should you Attend
      Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This bootcamp will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

      Areas Covered in the Session
      Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)
      Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)
      Examples of Typical Approaches for Excel Validation
      How to tailor your risk based methodology to Excel to determine the level of validation required
      Who Will Benefit
      VP of IT
      Director of IT
      Quality Managers
      Project Managers (for CSV / IT)
      Validation Specialists
      Database Administrators
      System Administrators
      Directors /Senior Directors of Discovery
      Directors /Senior Directors of Development
      Directors /Senior Directors of Commercialization
      Document Managers
      Training Managers
      Regulators
      Speaker Profile
      Angela 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.

      Cost: Payment required - $290. One Attendee

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.