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21CFR 11 Compliance for Excel Spreadshee

6/19/2014 10:00 AM - 11:00 AM

Course Objective:

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.

Course Outline:

Requirements for Excel Spreadsheets

FDA Part 11 Validation Guidance

Compliance Problems with Spreadsheets

Design Specifications for 21 CFR 11 compliance

Documentation for Part 11

Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Target Audience:

Quality Managers

Quality Engineers

Small business owners

GxP

Consultants

Quality VPs

IT VPs

Price List :

$ 219.00 Single Attendee

$ 689.00 Group – Max 10 Attendees per location

$ 249.00 Access Recorded Version online

$ 349.00 Buy Training CD-DVD .

Learn More: 21CFR 11 Compliance for Excel Spreadshee

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