Compliance4All, Online
2017-01-04
Overview: Excel® Applications are widely used in laboratories, offices and
manufacturing e.g., for data capture, data manipulation and report
generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require
users of software and computer systems to demonstrate and document
data accuracy, integrity and confidentiality.
Areas Covered in the Session: FDA and other agency's requirements for spreadsheet validation -
What do inspectors ask and what documents should be available. Learning from FDA warning letters related to spreadsheets How to design spreadsheets for Part 11/GxP/Annex 11 compliance Validation during design, development, installation and on-going use When, what and how much to test?
For Easy Implementation, Attendees Will Receive User Manual with Excel functions that help to comply with FDA
requirements SOP: Validation of spreadsheet applications SOP: Development and use of spreadsheets in regulated environments Gap analysis/checklist for Macros and Spreadsheet applications
Who Will Benefit: Pharmaceutical and medical device industry Contract laboratories All developers and users of spreadsheet applications Validation specialists
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