World Conference Calendar

33622 Conferences

Production and QMS Software Validation - An Excel Example

Added by Referral on 2012-01-05

Conference Dates:

Start Date Start Date: 2012-01-18
Last Date Last Day: 2012-01-18

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

This webinar covers production and QMS requirements for software (Excel spreadsheet) built into a medical device, as outlined in 21 CFR 820.70(i). Get practical advice on writing validation protocols and reports for Excel spreadsheets.

Why Should You Attend:

If you use software as part of your Production or Quality Management System (QMS) you must validate the software. This requirement is not the same as for software built into a medical device. Production and QMS software requirements are in 21 CFR 820.70(i). The most common occurrence of this kind of software involves an Excel spreadsheet. This webinar gives you practical advice on recognizing when this happens.

While the requirement applies to all production & QMS software, Excel spreadsheets are a good way to illustrate the methods. In addition, if you use Excel to create quality records, you may need to satisfy the Part 11 requirements.

The presentation explains the regulations in plain language and uses the FDA guidance documents to illustrate them. For validation, you will learn data checking methods in Excel and how to use them as part of a software validation approach. You will learn methods to document calculations in spreadsheets, prepare validation protocols, and produce validation reports.
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