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2 Days Workshop: Computer Systems Validation (CSV) for Excel Spreadsheets (San Diego, CA, United States - December 14-15, 2017) - Research and Markets
[October 30, 2017]

2 Days Workshop: Computer Systems Validation (CSV) for Excel Spreadsheets (San Diego, CA, United States - December 14-15, 2017) - Research and Markets


The "2 Days Workshop: Computer systems Validation (CSV) for Excel Spreadsheets" conference has been added to Research and Markets' offering.

Spreadsheets such as Excel are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

GxP records generated by spreadsheet calculations are electronic records and should comply with FDA's 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users o create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.



This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training.

Areas Covered


Part 11 / Annex 11 Computer Systems Validation (CSV) is to be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

It will address the following topics:

1. Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)

2. Risk Based Approach and Controls to Excel Spreadsheets (incl. Excel specific risks)

3. Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)

4. The FDA's Perspective and Use of Spreadsheets

5. Examples of Typical Approaches for Excel Validation

6. How to tailor your risk based methodology to Excel to determine the level of validation required

7. 483s and Warning Letters for Excel and other Spreadsheets

8. Quiz: Test your understanding of Computer Systems Validation for Excel

For more information about this conference visit https://www.researchandmarkets.com/research/34vwsb/2_days_workshop


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