Spreadsheets in FDA Regulated Environments Conference

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

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501064LIVE?channel=mailer&camp=Webinar&AdGroup=govevents_Jan_2017_SEO
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