Excel Spreadsheet Validation for FDA 21 CFR Part 11

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Excel Spreadsheet Validation for FDA 21 CFR Part
11
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Speaker Profile

• Angela Bazigos is the CEO of Touchstone
  Technologies Silicon Valley, Inc. "Your Passport
  to Compliance". She has 30 years of experience in
  the Lifesciences industry spanning Project
  Management, Quality Assurance and Regulatory
  Affairs and has a patent aimed at speeding up
  Software Compliance.
• Ms Bazigos is a member of the SQA CVIC (Society
  of Quality Assurance Computer Validation
  Initiative Committee), ASQ, DIA and RAPS and
  consults to investment groups on Lifesciences
  investments as well as Pharma / Biotech / Medical
  Device companies on compliance matters, including
  strategy, submissions, quality assurance and
  remediation following action by the FDA. She
  teaches classes on Compliance, 21 CFR 11,
  Computer Systems Validation, and Project
  Management both to investor groups and industry. 
   

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Overview

• 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.
• 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.

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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
• How does the FDA Design and Use spreadsheets
• Documentation for Part 11
• Future Trends in 21 CFR 11 compliance for Excel
  Spreadsheets

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