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  • Validation and Use of Excel® Spreadsheets in Regulated

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Dec 05, 2013 10:00 AM
  • End Time:
  • Thursday - Dec 05, 2013 11:30 AM
  • Location:
  • Online
  • This excel validation training/ webinar will demonstrate how to design spreadsheets for part 11/GxP /SOX/HIPAA, document planning, specifications, installation, testing and changes to meet FDA requirements.

    Why Should You Attend:
    Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® the requirements can be met. This webinar will demonstrate how requirements will be met.

    Who will benefit:
    -Pharmaceutical and medical device industry
    -All developers and users of spreadsheet applications
    -Validation specialists
    -QA managers and personnel
    -Regulatory affairs personnel
    -Production and lab managers
    -Training department
    -Documentation department
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